CLINICAL DATA MANAGER JOB DESCRIPTION

A Clinical Data Manager governs what pharmaceutical and biotech sponsors can actually trust when they submit to the FDA. The role owns the design, validation, and lock of clinical databases under ICH E6 Good Clinical Practice standards, operating within a trial team that spans biostatistics, clinical operations, and drug safety. When eCRF specifications are misaligned with a protocol, or edit checks miss a dosing inconsistency, the downstream cost falls on the study - not on data entry. Catching that before database lock is the job.

As the Clinical Data Manager, you ensure that clinical trial data collected under GCP and CDISC standards is accurate, complete, and inspection-ready from study start-up through database lock. You work across sponsor teams, contract research organizations, and investigator sites, reporting into data management leadership within a pharmaceutical or CRO environment.

Career Impact: Owning the Data Management Plan and Trial Master File documentation for IND-stage and NDA-supporting studies establishes deep regulatory credibility that transfers across pharma, biotech, and CRO organizations.

Business Impact: Regulatory submissions depend directly on the integrity of the data this role certifies - a delayed or deficient database lock can postpone an NDA filing by months and cost sponsors significantly.

Growth Opportunity: Demonstrated competency in CDISC SDTM, vendor oversight, and cross-functional study leadership opens paths to Senior CDM, Principal CDM, or data management director roles within global development programs.

• Design eCRF specifications and edit check logic to capture protocol-required data accurately across assigned clinical studies.
• Develop and maintain the Data Management Plan, CRF completion guidelines, and annotated CRF documentation for each study.
• Validate electronic data capture databases through user acceptance testing, including review of build specifications and documentation of results.
• Monitor data quality by reviewing listings, resolving queries with investigator sites, and overseeing medical coding against MedDRA and WHODrug dictionaries.
• Coordinate database lock activities, including final data review, query resolution, and sign-off from biostatistics and medical monitors.
• Oversee external data transfers and reconcile third-party data sets against the clinical database to ensure completeness before lock.
• Partner with biostatistics, clinical operations, drug safety, and CRO teams to align data review plans, timelines, and study milestones.
• Guide junior data management staff on study-specific processes and GCP compliance standards.

• Bachelor's degree in a scientific, statistical, or computer science field, or equivalent work experience.
• 3 or more years of clinical data management experience in a pharmaceutical, biotech, or CRO setting, with demonstrated study ownership from start-up through lock.
• Working knowledge of FDA, ICH, and GCP regulatory requirements governing clinical trial data collection and management.
• Proficiency in CDISC standards including CDASH data collection standards and SDTM submission specifications.
• Experience designing and reviewing eCRF specifications, edit check programs, and data validation plans.
• Ability to manage query resolution workflows with investigator sites and maintain audit-ready Trial Master File documentation.
• Strong written and verbal communication skills for coordinating across sponsors, CROs, and cross-functional study teams.
• Demonstrated organizational skills with ability to manage multiple studies under competing timelines.

• Certified Clinical Data Manager (CCDM) credential from the Society for Clinical Data Management.
• Experience overseeing CRO data management vendors, including review of deliverables against contracted scope and SOPs.
• Familiarity with statistical analysis plan review and support for clinical study report data sections.
• Knowledge of 21 CFR Part 11 electronic records requirements and their application to EDC system validation.

• Database lock date adherence, measured as days variance against the protocol-defined lock milestone.
• Query resolution cycle time, reflecting how quickly open data discrepancies are closed with investigator sites.
• eCRF completion rate at key data cuts, tracking the percentage of expected records entered and verified.
• Medical coding completion percentage at each data cut, measured against total adverse event and medication terms requiring coding.
• Trial Master File document filing timeliness, measured by percentage of data management documents filed within required windows.
• Typical tools: Electronic Data Capture platforms (commonly Medidata Rave or Veeva Vault CDMS); statistical programming environments (commonly SAS or R).

• Base Salary Range: $75,000 to $115,000 annually depending on seniority and location.
• Bonus: Annual performance bonus typically 5% to 12% of base salary.
• Equity: Stock options or RSUs common at biotech employers; less common at CROs.
• Health Benefits: Medical, dental, and vision coverage standard across pharma and CRO employers.
• PTO: 15 to 20 days annually plus company holidays; some employers offer flexible PTO.
• Common Perks: Professional development funding, CCDM exam support, and remote or hybrid work arrangements.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Background screening, including verification of employment history and criminal record, is a condition of employment for all positions. Reasonable accommodations for qualified individuals with disabilities are available throughout the application and employment process upon request. All applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected under applicable federal, state, or local law. Candidates must hold current authorization to work in the United States without requiring employer sponsorship.

The Clinical Data Manager owns the end-to-end data management of assigned multi- and single-center clinical trials, including eCRF design, EDC system validation, and Trial Master File readiness within a neurological clinical research institute. Reporting to the Director of Data Management and collaborating with junior staff, funding organizations, and regulatory offices, the Clinical Data Manager ensures data integrity across study start-up, conduct, and close-out to support inspection and submission outcomes.

Key Responsibilities

• Participate in protocol review and development.
• Facilitate the study kick-off meeting.
• Develop and design Electronic Case Report Forms (eCRFs).
• Design, test, and validate the study-specific electronic data capture system.
• Develop programs to check the integrity of the data, including range, error, and logic checks.
• Review data and assist in data safety report generation on a regular basis.
• Develop and manage the process for adverse event monitoring and reporting.
• Assist study sites with Electronic Data Capture (EDC) system-related questions or problems.
• Perform regular internal audits on the above activities.
• Draw on previous data management experience and knowledge of FDA regulations to participate in the design and implementation of new modules for the Clinical Trial Management System as well as proposed changes to the existing system.
• Develop workflow schemas for new functionality.
• Provide direction and guidance to program developers for all segments of new functionality.
• Elicit, compile, and present feedback from team members regarding proposed functionality for EDC and CTMS.
• Accept responsibilities for special projects as requested.
• Ensure required study-specific data management documents in the Trial Master File are of high quality and filed contemporaneously to support inspection and submission readiness activities.
• Assist with developing and maintaining best practice guidelines, study tool templates, and Standard Operating Procedures.

Required Qualifications

• Bachelor's degree required.
• 3+ years of experience in clinical data management required.
• Experience with web-based EDC or CTMS.
• Demonstrated knowledge of data management processes and principles.
• Working knowledge of clinical research, industry standards including CDISC, FDA, ICH, GCP, GCDMP, and related regulatory requirements.
• Familiarity with MedDRA and WHO-Drug.
• Proficiency in Microsoft Office Suite including Outlook, Word, and Excel.
• Ability to work independently and manage multiple studies.
• Ability to develop and manage positive relationships with academic and industry sponsor representatives.
• Ability to provide guidance and training to team members.
• In-depth understanding of Good Clinical Data Management Practice guidelines and relevant FDA regulations.
• Basic understanding of drug manufacturing process and ability to interpret relevant regulations.

Embedded within the data management function, the Clinical Data Manager delivers expertise and support across eCRF specification development, cross-functional data review, and process improvement initiatives for internal project teams and contract research organizations. Working closely with clients, sponsors, and vendor teams, the Clinical Data Manager builds quality data management programs that sustain timeline performance and budget compliance across the full project lifecycle.

Core Functions

• Provide data management expertise and support to internal project teams, clients, and Clinical Research Organizations.
• Plan, perform, and oversee development of specifications for eCRFs, edit checks, electronic data handling, manual review, and execution of User Acceptance Testing.
• Conduct and orchestrate scheduled cross-functional data review, identification of issues, and track through resolution.
• Participate in innovation and implementation of new technologies resulting in data management process improvements.
• Ensure adherence to quality control procedures for data management activities.
• Write appropriate Standard Operating Procedures and training guidelines, and oversee revisions and updates for data management activities.
• Facilitate and provide oversight of internal study team, client, and vendor meetings.
• Actively review and provide feedback on study data quality, including data management metrics, and review project scope to identify and report out-of-scope activities.
• Manage and monitor timelines, assuring resources are available to meet milestones.
• Identify inconsistencies and inefficiencies in data management processes and recommend solutions.
• Assist in preparation of proposals and budgets for new projects, and manage budgets for ongoing projects.

Qualifications & Experience

• Bachelor's degree or above with 12+ years of data management experience, or 8+ years with a Bachelor's degree, or 6+ years with a Bachelor's degree in a relevant field.
• 4+ years of experience in the pharmaceutical, biotechnology, or contract research organization environment.
• 6+ years of experience supervising clinical data managers and team activities.
• Experience with various data collection and Electronic Data Capture systems and related tools and processes.
• Good knowledge of FDA, EMA, and ICH guidelines, and Good Clinical Practices, including regulatory requirements for clinical development programs.
• Strong analytical and research skills.
• Excellent written and verbal communication skills.
• Strong attention to detail and highly organized.

Reporting to senior data management leadership, the Clinical Data Manager shapes all data management activities for one or more clinical trials, including Data Management Plan development, quality risk assessment, and database release within a biopharmaceutical or contract research organization setting. Partnering with internal and external service providers and cross-functional study teams, the Clinical Data Manager advances data acquisition standards and operational excellence to support regulatory-compliant trial outcomes.

Primary Duties

• Serve as clinical data manager for one or more clinical trials, assuming responsibility for all data management activities including selection of data acquisition standards, Data Management Plan, quality risk indicators, and third-party study data due diligence.
• Participate in and ensure quality database design, including documentation, testing, and implementation of clinical data collection tools.
• Serve as a technical resource to study teams and clients for data management standards, tools, data provisioning, and reporting.
• Partner with internal and external service providers to deliver high-quality data management for all assigned studies.
• Proactively drive quality and efficiency to meet timelines and milestones, ensuring scientific and operational excellence in collaboration with the cross-functional study team.
• Ensure work carried out by data management providers is in accordance with applicable SOPs and working practices.
• Ensure required study-specific documents in the Trial Master File are of high quality and filed contemporaneously.
• Ensure operational excellence in application of standards, data acquisition, proactive data review, data integrity monitoring, data cleaning, electronic data processing, data access and visualization, and database release.

Skills & Qualifications

• Minimum 5 years of data management experience required.
• Demonstrated experience in all relevant clinical data management activities in a biopharmaceutical or contract research organization setting.
• Working knowledge of all phases of clinical trials and ability to assess study requirements from protocol review.
• Working knowledge of clinical research, FDA, ICH, GCP, GCDMP, and related regulatory requirements.
• Advanced programming capacity and data visualization using standard data science tools such as R, Python, SAS, or SPSS.
• Strong project and risk management skills.
• Vendor oversight experience preferred.
• Detail-oriented, motivated, and strategic with time management and organizational skills.

Sitting at the intersection of data governance and cross-functional collaboration, the Clinical Data Manager leads CRF design and validation, EDC system build, and bid defence representation within a clinical research organization supporting sponsor companies. Operating across internal departments, external data providers, and sponsor project teams, the Clinical Data Manager delivers high-quality data management across the full duration of each clinical trial to support company-wide project success.

Duties

• Develop and review data management procedures for clinical trials with sponsor companies and other departments.
• Lead the design and validation of CRF specifications and edit checks for the electronic data capture system used for each study.
• Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members.
• Interact with external data providers and all project team members within the cross-functional team.
• Attend bid defence meetings, teleconferences, and face-to-face sponsor meetings as the lead representative from data management.

Requirements

• Bachelor's degree or Master's degree in a science or mathematics-related field with strong or good data management experience in clinical trials.
• Experience operating as primary contact for data management activities, including project oversight and direct vendor or client interaction.
• Understanding of database structure and processes in data management.
• Basic knowledge of medical terminology and clinical research methodologies.
• Computer experience with database, spreadsheet, and EDC software such as SAS, Oracle Clinical, or similar systems.

A key member of the clinical data team, the Clinical Data Manager leads Case Report Form design, eCRF validation, and query resolution for investigator sites while maintaining Data Management Plans in compliance with regulatory guidelines. Collaborating across the clinical operations function, the Clinical Data Manager builds data integrity processes that support clean, audit-ready trial databases from study initiation through close-out.

Functions

• Design Case Report Forms and provide database requirements and specifications, including field definitions, automatic edit checks, indication of critical variables, and CRF completion guidelines.
• Assist in query design using SQL to check for missing or inconsistent eCRF data.
• Understand, update, and optimize existing queries and reports.
• Correspond with investigator sites to obtain and track resolutions to queries.
• Analyze data to uncover potential issues, inconsistencies, and areas of concern.
• Validate eCRF data, including scrubbing, cleaning, query generation, and applying data handling conventions.
• Train users on EDC functionality.
• Provide necessary documentation in compliance with existing standard operating procedures and regulatory guidelines.
• Maintain necessary clinical trial conduct documentation, including Data Management Plans.

Experience & Qualifications

• Certified Clinical Data Manager certification preferred.
• At least 2 years of clinical data management experience and clinical research experience.
• Comprehensive knowledge of regulations pertaining to human subject protection, including 21 CFR, 45 CFR 46, and HIPAA.
• Excellent computer skills including proficiency in SQL and MS Office products.
• Experience working in an FDA-regulated environment a plus.
• Experience with various EDC systems such as Medidata Rave, Caisis, or InForm preferred.
• Comfortable working in a fast-paced environment.
• Effective communicator, capable of determining how best to reach different audiences.
• Able to hold self and others accountable to achieve goals and meet commitments.

Accurate, compliant clinical databases depend on the Clinical Data Manager, who leads eCRF preparation, SAS-based EDC programming, edit check management, and database lock across both in-house and outsourced studies. Based within a pharmaceutical or biotech data management team, the Clinical Data Manager delivers cross-functional data quality oversight from study planning through final database lock to support downstream regulatory submissions.

Accountabilities

• Participate in planning and support of clinical studies.
• Prepare eCRFs and lead the team review ensuring compliance with applicable standards.
• Build or participate in the EDC build.
• Program and manage edit check specifications.
• Program EDC custom functions in SAS.
• Plan, facilitate, and document EDC user acceptance testing and document data review by other functional groups.
• Reconcile external data sets and safety database with clinical database using SAS.
• Issue and resolve system and manual queries.
• Plan and conduct database lock.
• Oversee contract research organization data management activities for outsourced studies.

Technical Qualifications

• Bachelor's degree or above with a minimum of 5 years of experience in the pharmaceutical or biotech industry as a clinical data manager.
• Experience with Medidata RAVE, Veeva Vault CDMS, or similar systems.
• Understanding of MedDRA and WHODRUG coding processes.
• Strong project management experience.
• Excellent verbal, written, and organizational skills with the ability to work cross-functionally.
• Ability to work in a fast-paced environment managing multiple tasks.

As the Senior Clinical Data Manager, this role leads study start-up tasks including CRF design, edit check creation, and user acceptance testing while providing ongoing operational support for database migrations, data transfers, and database lock activities across multiple high-volume, complex studies. The data management program relies on this work to ensure complete, accurate, and regulatory-compliant data that supports publications and submissions within a CRO or in-house development setting.

Leadership Responsibilities

• Act as primary or supporting data manager for study-specific start-up tasks, including CRF design, edit check creation, CRF completion guideline creation, and user acceptance testing, including leading process improvements as needed.
• Participate in and lead data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
• Participate in and lead the development and maintenance of the data management plan.
• Participate in or lead ongoing operational support for all activities during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, and support for database lock and archiving activities.
• Ensure medical coding is completed quickly, completed for all data cuts, and reviewed and approved by medical monitors.
• Ensure user administration in data management-owned systems and Trial Master File document filing is accurate and timely.
• Independently monitor activities and project status for successful deliverables according to the timeline while participating in initiatives to streamline data management processes.

Position Requirements

• Bachelor's degree in a scientific discipline or equivalent.
• 4+ years of relevant experience in clinical data management, or equivalent experience at a hospital or research site with knowledge of medical terminology and clinical data processing.
• Experience with clinical trial protocols and data collection documents such as CRF completion guidelines or data management plans.
• Knowledge of regulatory requirements for the conduct of clinical data management in global trials preferred.
• Competence with electronic data management systems such as Medidata Rave, Oracle Inform, or Veeva EDC.
• Proficiency in MS Office programs including Word, Excel, and PowerPoint.
• Highly effective written and verbal communication skills for interacting professionally with personnel at all levels.
• Strong organizational skills with ability to work on multiple projects simultaneously.
• Experience in solving complex problems, taking appropriate corrective action, and implementing improvements.
• Ability to work under challenging timelines in multi-player environments with sound judgment and effective time management.

Clinical Data Manager leads data management service delivery for clinical trial customers, authoring data management plans, performing user acceptance testing, verifying data extracts, and representing the function in client audits and bid defences. Success in the position means maintaining proactive data monitoring, mentoring junior staff, and driving process improvements that reduce processing times and sustain data quality across all assigned studies.

What You'll Do

• Collaborate across functional groups to address technical issues impacting quality and drive forward technical initiatives within data management.
• Provide data management guidance to internal project team members and customers.
• Communicate with internal project team members and customers on all aspects of data management activities performed for a study.
• Author data management plans.
• Perform user acceptance testing on reports.
• Review, make decisions, and act upon output from automated data checks.
• Facilitate risk assessments for mid-study changes.
• Verify data extracts against the data transfer specifications.
• Provide proactive data monitoring per contractual obligations.
• Contribute to the development and update of process improvements that reduce processing times, increase quality, and meet departmental and corporate objectives.
• Assist in developing and improving Standard Operating Procedures, Working Instructions, and Best Practices.
• Mentor less experienced staff and ensure project staff are trained and adhere to project-specific, standardized data management processes.
• Represent clinical data management in client visits, audits, inspections, and bid defences as needed.

Knowledge Skills & Abilities

• Bachelor's degree in a relevant field such as medicine, statistics, or computer science, or equivalent work experience.
• 5+ years of professional experience in the clinical trials data management field.
• Experience in providing data management services in the clinical trials industry.
• Familiarity with 21 CFR Part 11 or experience in a regulated environment.
• Ability to complete high-quality technical documentation.
• Proficient in Access, Excel, and other office software technologies and applications.
• Extreme attention to detail and strong organizational skills.
• Ability to quickly learn and apply new skills, procedures, and approaches.
• Ability to meet short deadlines and manage multiple tasks in a fast-paced environment with little direct supervision.
• Proven ability to work both independently and in a team-oriented environment.

The Clinical Data Manager owns the creation and review of study-specific CRFs and EDC databases, medical coding, and data management documentation while providing mentorship and strategic guidance to junior staff across oncology-focused clinical trials. Reporting to the clinical data management function and collaborating with medical scientists and investigator teams, the Clinical Data Manager delivers accurate, regulatory-compliant data that supports study reporting and internal process improvement.

Day-to-Day Responsibilities

• Create and review study-specific electronic or paper Case Report Forms using prior knowledge, protocol-specific information, and departmental standards.
• Configure, migrate, and test electronic data capture databases based on internal procedures, study requirements, and system best practices.
• Develop database requirements for use by EDC vendors and work with vendors to obtain deliverables in a timely manner.
• Create and review study-specific data management and database documentation, including Data Management Plans, CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, and Edit Check Specifications.
• Attend study-specific team meetings and produce status reports and requested metrics, including query information and data trends.
• Perform data review, query generation and closure, and coding of verbatim terms such as adverse events and concomitant medications.
• Collaborate with medical scientists for coding, consistency, review, and approval, and incorporate coding files into the clinical database.
• Participate in the development of new processes or revision of existing processes.
• Train internal colleagues in clinical data management in informal or formal settings as needed.
• Train investigators and study coordinators at investigator meetings on CRFs, the EDC system, and CRF completion guidelines as needed.
• Provide analytical insight on data management strategies and advise the internal team with tactical strategies accordingly.
• Provide work direction, guidance, mentoring, and support to junior staff as necessary.

Professional Experience

• Bachelor's degree in science or related field.
• 2 to 5 years of clinical data management experience.
• Oncology and RECIST experience strongly preferred.
• Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines.
• Experience working with EDC clinical databases.
• MedDRA and WHO Drug coding experience.
• Knowledge of CDISC and SDTM standards.
• Excellent English verbal and written communication skills with good organizational and interpersonal skills.

Embedded within a pharmaceutical or contract research organization data management team, the Clinical Data Manager delivers eCRF development, database build oversight, and vendor coordination while establishing cross-functional data review plans and ensuring all milestones align with company goals. Working closely with biostatistics, statistical programming, clinical operations, drug safety, and external vendors, the Clinical Data Manager leads GCP inspection readiness and regulatory-compliant data delivery across the full study lifecycle.

Scope of Work

• Contribute to data management activities in support of clinical studies, including eCRF development, database build activities, monitoring data collection and cleaning, and oversight of database lock and data archiving.
• Collaborate with internal and external partners including biostatistics, statistical programming, clinical operations, medical, quality assurance, drug safety, and pharmacovigilance teams, as well as contract research organizations and vendors.
• Establish cross-functional internal data review plans, coordinate data cuts and transfers, and conduct data reviews.
• Review data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications, and other study documentation.
• Represent data management and effectively communicate requirements, strategy, timelines, and deliverables at internal and external meetings.
• Participate in the drafting and review of timelines consistent with company goals and ensure all deliverables and milestones are met.
• Review clinical protocols, amendments, clinical study reports, statistical analysis plans, and related documents.
• Support GCP inspection readiness activities.

Education & Experience

• Bachelor's or associate's degree in a scientific discipline with over 4 years of related experience in a pharmaceutical or contract research organization setting.
• Strong knowledge of eClinical processes and efficient design and build of EDC data management systems and other clinical trial systems.
• Knowledge of regulations and industry-adopted data standards such as CDISC SDTM and CDASH.
• Experience working with Medidata Rave EDC.
• Experience using standardized medical terminology including MedDRA and WHODrug.
• Experience working with MS Office Suite including Excel, Word, and PowerPoint, and familiarity with MS Project.
• Understanding of ICH GCP and general knowledge of industry practices and standards.
• Knowledge of regulatory requirements for clinical data systems including 21 CFR Part 11.
• Highly motivated and flexible, with excellent organizational and time management skills.

Reporting to senior clinical data managers, the Clinical Data Manager shapes data quality across study start-up through database lock by reviewing CRFs, managing medical coding, maintaining project documentation, and leading EDC and IRT system training. Partnering with project team members, sub-CROs, and vendors, the Clinical Data Manager delivers data integrity and regulatory compliance across all assigned studies to support GCP inspection readiness and timely reporting.

Work Activities

• Support senior clinical data managers with all data management activities from study start-up to database lock.
• Review Case Report Forms, edit checks, data management listings, and query listings for data cleaning.
• Provide ongoing identification and resolution of errors and inconsistencies in clinical trial data to ensure high data quality.
• Create, review, and maintain global working practices, standards, and templates to support Good Clinical Practice inspection readiness.
• Lead training on electronic systems for the study, including EDC and IRT systems.
• Provide clear verbal and written communication and hands-on support to project team members and vendors related to CRF design, data quality, and reporting of study results.
• Ensure data integrity across projects following applicable regulatory standards, ICH, GCP, and SOPs.
• Monitor data clean-up process from study start-up through data archiving, including activities performed by vendors.
• Manage activities including medical coding, developing data validation checks, and managing database snapshots.
• Prepare and distribute project status reports to the project team and management.
• Create and maintain project documentation including Data Management Plans, eCRF Completion Guidelines, validation specifications, and work instructions for assigned projects.
• Work with the study team and coordinate all data management functions.

Background & Experience

• Tertiary qualifications in a scientific or IT-related field such as computer science.
• 2+ years of experience in clinical data management within a pharmaceutical, biotech, or contract research organization environment.
• Experience with clinical data registries preferable.
• Knowledge of clinical research, medical terminology, disease processes, and clinical practice.
• Understanding of GCP, ICH, and other regulatory requirements.
• Strong clinical systems understanding.
• Experience with common project management methodologies.
• Working knowledge of clinical database applications such as EDC, IWRS, and CTMS.
• Experience working with MS Office Suite including Excel, Word, and PowerPoint.
• Detail-oriented with strong problem-solving and critical thinking skills.
• Ability to adapt to internal and external deadlines and oversee vendors.

Sitting at the intersection of clinical statistics and data operations, the Clinical Data Manager leads statistical analysis planning, SOP maintenance, and GCP compliance for clinical trials and post-marketing investigations within a pharmaceutical company. Operating across in-department management, inter-departmental coordination, and external key opinion leader engagement, the Clinical Data Manager advances data management and statistical excellence to support regulatory submissions and organizational growth.

Performance Expectations

• Perform statistical analysis and data management activities.
• Create and maintain SOPs for statistical analysis related IT operations.
• Propose appropriate plans for clinical trials and post-marketing clinical investigations from the aspect of clinical statistics.
• Instruct clinical development personnel on statistical judgements and ideas related to clinical trials and post-marketing surveys.
• Create the statistical analysis section of clinical trial protocols.
• Manage data and IT technology including statistical analysis systems, databases, and reporting systems.
• Create the statistical analysis section of clinical trial summary reports.
• Prepare and respond to GCP field surveys and conformity document surveys for parts related to statistical analysis and data management.
• Manage in-department operations including people management, inter-departmental coordination, and proper execution of department budget.

Minimum Qualifications

• Practical experience in the clinical statistics department of a pharmaceutical company.
• Experience in creating statistical analysis plans or data management plans.
• Experience in discussions and negotiations with key opinion leaders regarding clinical statistics.
• 5+ years of experience in organisational management with advanced problem-solving, negotiation, and management skills.
• Has general knowledge of clinical trials and fully understands their ethical principles.
• Correct understanding of applicable pharmaceutical law, GCP, and other regulations and rules regarding clinical trials.
• Expertise in clinical statistical analysis, data management, and relevant ICH guidelines.
• Knowledge of advanced statistical analysis methods and ability to promote practical application.
• Basic Microsoft Office application operation skills.
• Opportunity to develop people management skills.
• Possibility to transition into a global pharmaceutical role.

A key member of the data management leadership structure, the Principal Clinical Data Manager leads assigned data management teams and coordinates project delivery from Data Management Plan implementation through database lock across multiple program-level studies. Collaborating across sponsors, third-party vendors, investigator groups, and internal stakeholders, the Principal Clinical Data Manager builds team capability and ensures smooth budget, resource, and timeline management to drive consistent data quality outcomes.

Ownership Areas

• Coordinate the work of the assigned data management team, including data managers assigned to projects within the program.
• Interact with and update all relevant stakeholders.
• Oversee budget and resource allocation.
• Prepare and participate in proposal bid defence meetings.
• Participate in and present at internal, sponsor, third-party, and investigator meetings.
• Ensure the smooth running of the data management plan from implementation to lock.
• Provide project-specific training to data management team members when required.

Required Qualifications

• Experience in leading projects from a data management perspective.
• Experience in all stages of the data management lifecycle.
• Proficient in at least one clinical data management system, with multiple systems advantageous.
• Strong project management skills within a clinical trial setting.
• Excellent written and spoken communication skills for interacting with internal and external stakeholders.
• Prior experience in a contract research organization or sponsor environment.

High-quality clinical and real-world data delivery depends on the Clinical Data Manager, who oversees Functional Service Provider work packages, data transfer agreements, and data surveillance strategies while advising internal teams on FAIR-compliant, fit-for-purpose data solutions. Serving as a subject matter expert across the organization and within cross-functional initiatives, the Clinical Data Manager leads vendor selection, sample management oversight, and stakeholder engagement to advance the function's technical and scientific data capabilities.

Areas of Ownership

• Collaborate with peers within the function and across the organization to identify, design, and execute fit-for-purpose data management solutions, ensuring FAIR principles are adhered to.
• Act as subject matter expert for data collection and acquisition, advising teams and stakeholders on best practices and proposing innovative solutions for new data types, technologies, and sources.
• Partner with and provide oversight of data management deliverables to Functional Service Providers and vendors.
• Provide quality assurance on tasks to ensure high-quality data and compliance with applicable pharmaceutical industry regulations and standards.
• Proactively manage timelines and track decisions, ensuring successful delivery of study work packages carried out at Functional Service Providers.
• Provide support in the form of business and technical expertise to Functional Service Providers where needed.
• Oversee Functional Service Provider activities in sample management and electronic manifest processes, ensuring timely and proactive resolution of queries.
• Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made within the function.
• Inform stakeholders of the status of key deliverables and act on changing milestones.
• Partner with stakeholders to understand their data insight needs and offer appropriate data management solutions.
• Partner with relevant functions for external data vendor selection and management, and oversee development of data transfer agreements ensuring use of standards and fit-for-purpose data models.
• Use data surveillance tools and strategies to provide aggregate-level reviews designed to identify patterns or anomalies in data and ensure high-quality results.
• Collaborate and contribute to functional and cross-functional initiatives to promote new ways of working, including emerging technologies.

Qualifications & Experience

• Bachelor's or Master's degree in life sciences, data science, computer science, bioinformatics, or equivalent industry experience.
• Experience in leading clinical data management study teams and maintaining oversight of all start-up, conduct, and close-out activities for multiple or complex studies.
• Experience in leading the collection of clinical trial and real-world data.
• Good understanding of molecule and disease area strategies, healthcare environments, and strong scientific and technical expertise.
• Knowledge of biological principles and understanding of data types including clinical, biomarker, WGS, and RNA-seq data.
• Strong understanding of the data flow from collection through to analysis and filing.
• Knowledge of CDISC data standards and ICH-GCP with experience working in regulated environments.
• Experience with data analytics and visualization tools and techniques.
• Demonstrated strong collaboration and excellent written and oral communication skills.
• Demonstrated leadership capabilities in decision-making, negotiation, and influencing.
• Demonstrated entrepreneurial mindset, self-direction, and willingness to learn new techniques.
• Ability to manage multiple requests and priorities.
• Proficient in English, both written and oral.

As the Clinical Data Manager, this role leads clinical study data management with moderate guidance, encompassing CRF design, Data Management Plan development, database schema definition, and programming support for international clinical research programs. The data management and programming team relies on this work to deliver and support compliant clinical databases across biomedical research projects, ensuring staff development, system administration quality, and accurate documentation throughout the study lifecycle.

Role Responsibilities

• Lead a clinical study with moderate guidance and monitor the progress of data management activities.
• Provide regular status reporting on data management progress.
• Review protocols for appropriate data capture tools, including Case Report Form design.
• Interact with data entry and review team members, programmers, study managers, and statisticians in designing CRFs and eCRFs and creating annotated CRFs and CRF completion guidelines.
• Develop data edit check specifications and run data listings as required.
• Develop the Data Management Plan for a clinical study.
• Enter data queries into the clinical data management system to be resolved at investigational sites and manage the resolution of those queries.
• Perform database lock and freeze activities per SOPs.
• Participate in regular team meetings and provide input when appropriate.
• Work with study teams to define requirements for creating the database schema and implementing quality control programming and edit checks.
• Provide programming support for clinical data management and reporting.
• Generate and maintain all required documentation including specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit check procedures, and import and export setup.
• Promote staff training and development, and manage general system administration and service quality.
• Build effective working relationships with team members.

Skills & Qualifications

• Preferred Bachelor's or associate's degree in computer science, statistics, or related field, or equivalent education and experience.
• 3 to 5 years of experience in clinical data management, including programming proficiency in Electronic Data Capture and data reporting or transformation languages such as SAS, R, or comparable tools.
• 3 to 5 years of experience working as part of an interdisciplinary team on biomedical research projects, specifically clinical trials.
• Experience with CDISC standards applied to clinical research databases.
• Knowledge and understanding of HIPAA regulations and Good Clinical Practice within clinical research.
• SAS and R programming skills preferred.
• Proficiency in Word, Excel, and PowerPoint.
• Excellent oral and written communication skills.
• Strong analytical, problem-solving, and decision-making capabilities.
• Ability to prioritize and manage multiple tasks to meet aggressive deadlines.
• Ability to work both independently and in a team environment.

Clinical Data Manager refines the full data management lifecycle for allocated clinical trials, including chairing Validation and Analysis Plan meetings, preparing CRFs and completion guidelines, and leading database freeze and lock activities within a drug development organization focused on data process innovation. The work directly supports high-quality, timely database locks and equips data management staff with the training and materials needed to sustain consistent standards across all assigned studies.

Job Functions

• Provide professional data management input on clinical trial teams, including input to and review of clinical trial database design and User Acceptance Testing.
• Chair the Validation and Analysis Plan meeting for clinical trials, write study-specific validation checks, and prepare necessary reports to ensure high-quality and consistent data.
• Identify errors and inconsistencies and resolve them or initiate their resolution via the field monitor or directly with the investigational site to ensure high-quality and timely database locks.
• Review and contribute to preparation of protocols specifically related to the data management section, visit schema, and study design.
• Prepare Case Report Forms and CRF completion guidelines, in electronic or paper format.
• Provide leadership and support for data management staff for allocated trials.
• Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, and final database lock.
• Perform training on data management software, practices, and trial-specific topics as required, and prepare training materials as needed.

Requirements

• University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree.
• 2+ years of experience in drug development with at least 2 years of experience in data management.
• Understanding of clinical trial methodology, GCP, and medical terminology.
• Good organizational and project management skills with intermediate presentation and problem-solving skills.
• Good communication and interpersonal skills.
• Ability to work well in a team and coordinate and provide direction on tasks to other data management team members.
• Fluent in English, both oral and written.

The Clinical Data Manager leads all facets of clinical data management from feasibility through closeout, including protocol-to-eCRF translation, UAT execution, medical coding, database QC, and audit preparation across study-specific EDC systems. Reporting to clinical operations leadership and collaborating with internal project teams and vendors, the Clinical Data Manager delivers high-quality data through disciplined design, validation, and cleaning to enable successful study outcomes.

Key Deliverables

• Translate protocols into eCRF and eSource specifications.
• Write UAT test scripts for eCRF and eSource forms.
• Perform and execute User Acceptance Testing.
• Track database set-up, testing, maintenance, and data entry metrics.
• Communicate with internal project teams and vendors on data management matters.
• Review study documents and develop project-specific guidelines and instructions.
• Design eCRF, Data Management, and Data Validation Plans and test EDC databases.
• Ensure data entry, follow-up, and validation, including manual CRF review and SAE reconciliation.
• Code medical data.
• Track and report metrics leading to database lock.
• Coordinate the processing, dispatch, and archiving of CRFs and queries.
• Maintain clinical data management working files.
• Perform database QC checks and prepare and attend audits.
• Train internal project teams on CRF completion and data management topics.

Experience & Qualifications

• College or university degree, or equivalent combination of experience and education.
• 3+ years of prior experience with clinical data.
• Experience with clinical data management systems such as Medidata Rave, Oracle InForm, ClinTrial, or Medrio.
• Working knowledge of CDISC, CDASH, and SDTM.
• Ability to write test scripts for User Acceptance Testing.
• Ability to conduct data review in accordance with the study protocol and data management plan.
• Ensure compliance with regulatory requirements and GCP.
• Strong organizational and time management skills.
• Ability to work independently and manage multiple tasks.

Embedded within a companion diagnostics program, the Clinical Data Manager delivers robust data management plans, data transfer agreements, and regulatory data reports for analytical validation and clinical studies spanning molecular biology, genomics, and oncology assays. Working closely with clinical operations, statistics, data science personnel, and external partners, the Clinical Data Manager builds compliant, accurate data processes that underpin regulatory filings and platform-level study outcomes.

Operational Focus

• Collaborate with pharma partners and contract research organizations to manage ongoing data cleaning, data locks, and provide support for data analysis.
• Develop, execute, and maintain robust and compliant data management plans.
• Review and assist with development of data transfer agreements and data specifications.
• Recognize process improvement needs and collaborate with other personnel to address them.
• Draft data reports for regulatory filings.
• Contribute to the development and implementation of departmental policies, standards, and protocols.

Technical Qualifications

• Bachelor's degree with a major in a scientific or other relevant field.
• 2+ years of clinical data management experience in a life sciences organization.
• Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.
• Familiarity with molecular biology, genetics, and genomic sequencing desired.
• Experience working with medical devices, diagnostics, or oncology assays desired.
• Familiarity with CDISC standards including SDTM desired.
• Experience with Electronic Data Capture software desired.
• Exceptional organizational skills and attention to detail.
• Ability to work cooperatively and communicate effectively with team members.
• Highly motivated with ability to work independently.