CLINICAL DATA ASSOCIATE JOB DESCRIPTION

A Clinical Data Associate manages the full data record of a clinical trial - not the science, but the integrity of every number behind it. This means owning the Data Management Plan from study start-up through database lock, resolving queries raised against subject data, and ensuring that what sites enter matches what sponsors can defend before an FDA reviewer. GCP compliance and ICH guidelines are the governing standard, not a background condition. The role sits within clinical operations, reporting into data management leadership, and works daily alongside biostatisticians, CRAs, and CRO partners.

As the Clinical Data Associate, you are accountable for the accuracy, traceability, and regulatory readiness of clinical trial data across one or more assigned studies. You operate within a cross-functional data management team, coordinating between internal clinical leads, external CRO vendors, and study sponsors to keep data deliverables on schedule and audit-ready.

Career Impact: Deep, hands-on ownership of DMPs, eCRF design, and SAE reconciliation builds the kind of verified GCP expertise that distinguishes a data professional in pharmaceutical and biotech hiring markets.

Business Impact: When subject data is incomplete, inconsistent, or unresolved at database lock, regulatory submissions stall - this role is the operational checkpoint that prevents that outcome across every assigned protocol.

Growth Opportunity: Experience spanning Phase 1 through Phase 3 study types, including blinded and randomized trials, creates a direct path toward Senior CDA, Data Manager, or CDM leadership roles within CRO or sponsor organizations.

• Develop and maintain the Data Management Plan for each assigned study, ensuring alignment with protocol design and regulatory standards.
• Review subject data listings for accuracy, consistency, and protocol compliance throughout the study lifecycle.
• Generate, track, and resolve data queries and clarifications in coordination with site staff and the study team.
• Draft and maintain data management documents including eCRF Completion Guidelines, Data Validation Specifications, and edit check scripts.
• Perform User Acceptance Testing for clinical databases, including writing and executing test scripts to validate data entry screens.
• Reconcile Serious Adverse Event data between clinical and safety databases to ensure cross-functional alignment.
• Coordinate with CRO partners and EDC vendors on data transfer agreements, timelines, and issue resolution.
• Support database lock activities by conducting final data reviews and ensuring all outstanding queries are resolved.

• Bachelor's degree in life sciences, health informatics, statistics, or equivalent work experience.
• 2 or more years of clinical data management experience, with direct involvement in study start-up, data cleaning, or database lock activities.
• Working knowledge of ICH/GCP guidelines and FDA regulations governing clinical trial data integrity.
• Experience developing or contributing to data management plans, eCRF guidelines, or data validation specifications.
• Demonstrated ability to generate, track, and resolve data queries within an electronic data capture environment.
• Familiarity with medical coding conventions including MedDRA or WHODrug terminology.
• Strong organizational skills with the ability to manage multiple concurrent study assignments and shifting timelines.
• Clear written and verbal communication skills, with the ability to document processes and interact with sponsors and cross-functional teams.

• Prior experience supporting SAE reconciliation or adverse event abstraction and grading against protocol-specified criteria.
• Exposure to vendor or CRO management, including participation in UAT planning or data transfer agreement negotiation.
• Knowledge of SDTM or CDISC data standards as applied in Phase 2 or Phase 3 submission-track studies.
• Background in oncology or other therapeutic areas requiring complex protocol-specific data review processes.

• Query resolution rate, measured as percentage of open queries closed within study-defined SLA windows.
• Database lock timeliness, tracking whether assigned studies reach lock on or before the target date.
• UAT defect rate, reflecting the number of post-go-live database issues attributable to incomplete testing.
• SAE reconciliation cycle time, measuring days from discrepancy identification to confirmed resolution.
• DMP version accuracy, tracking how often plan amendments require rework due to protocol misalignment.
• Typical tools: Electronic data capture (commonly Medidata Rave or Oracle InForm); statistical programming (commonly SAS); office productivity (commonly Microsoft Excel and Word).

• Base Salary Range: $55,000 to $85,000 annually, depending on seniority and setting.
• Bonus: 5% to 10% annual performance bonus typical in CRO and pharma environments.
• Equity: Rare at this level; stock purchase plans offered at larger pharmaceutical employers.
• Health Benefits: Medical, dental, and vision coverage; employer contribution varies by organization.
• PTO: 15 to 20 days annually, plus standard federal holidays.
• Common Perks: Remote or hybrid work options, professional development funding, and conference attendance support.

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

Background check completion, including where applicable a drug screening consistent with clinical research industry standards, is a condition of employment. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, age, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available to individuals with disabilities throughout the hiring process upon request. Candidates must be authorized to work in the United States.

The Clinical Data Associate owns the integrity of clinical study data by reviewing EDC system entries, generating queries, and drafting core data management documents, including the Data Management Plan and Data Validation Specification. Reporting to the Data Manager and collaborating with project leaders, clinical team members, and Sponsors, this associate enables accurate, audit-ready data that supports regulatory compliance across the drug development process.

Key Responsibilities

• Review clinical study data using EDC systems, generate queries as needed, and coordinate with site data entry staff to ensure accurate data reporting.
• Draft data-related manuals and plans, including the Data Management Plan (DMP), Data Review and Quality Specifications (DRQS), eCRF Completion Guidelines, and Data Validation Specification (DVS).
• Submit manuals and plans to the Data Manager for final review and approval.
• Perform database User Acceptance Testing, including script writing and execution.
• Maintain and track monthly clinical research project data metrics to analyze, identify, and report data trends.
• Assist Data Manager with data coding and maintaining appropriate WHODrug and MedDRA licenses.
• Assist Data Manager with data reconciliation, including adverse event (AE), serious adverse event (SAE), and external lab data reconciliation.
• Assist in performing bi-annual reviews of database users in collaboration with project managers.
• Represent the Clinical Data Management department in Sponsor meetings, audits, and project team meetings.
• Maintain established timelines for assigned projects.
• Work extensively with project leaders, clinical team members, and Sponsors in managing clinical data needs.
• Encourage collaborations and build working relationships with functional groups contributing to the project plan.
• Liaise with clinical, safety, and regulatory organizations for coordination of clinical trial activities.
• Assist with writing controlled documents and department training modules related to the Data Management function.
• Participate in training clinical team members.

Required Qualifications

• Associate's degree or higher, with preference for degrees in health science, statistics, or data management.
• Minimum 3 years of data coordination or data management experience in a biotechnology, pharmaceutical, academic, or contract research organization setting.
• Experience with clinical data management, clinical study database design and implementation, and generation of data reports and listings.
• Strong knowledge of the clinical drug development process.
• Demonstrated skill with establishing and documenting standard processes for project tracking data collection, updates, and reporting.
• Experience with hands-on management and testing of clinical databases.
• Experience utilizing programs to code medical terms and medications.
• Experience with commercial electronic data capture systems such as Medidata Rave and Oracle Inform.
• Strong computer skills with proficiency in Microsoft Office applications.
• Strategic thinking, contingency planning, and problem-solving skills.
• Strong interpersonal and communication skills, both oral and written.
• Ability to work collaboratively with cross-functional teams.
• Excellent planning and organizational skills.

Embedded within the data management team, the Clinical Data Associate delivers accurate subject data collection and review by applying protocol-specified guidelines across study start-up, maintenance, and finalization tasks. Working closely with the data management team and Data Management Lead, this associate supports quality study execution and client satisfaction through disciplined query management and database oversight.

Core Functions

• Review study protocols and apply protocol-specified guidelines to the collection, processing, review, and cleaning of subject data.
• Support study start-up, maintenance, and finalization tasks as defined by the Data Management Lead.
• Develop databases and edit checks for the collection of subject data.
• Develop data management and validation plans.
• Develop listings for the review of subject data.
• Review subject data and identify findings.
• Raise and address queries on subject data.
• Work in electronic data capture systems.
• Freeze and lock subject data.
• Produce study and subject reports.
• Work closely with the data management team to ensure quality study execution and client satisfaction.

Qualifications & Experience

• Undergraduate degree or equivalent.
• Working knowledge of MS Word, Excel, PowerPoint, and Adobe Acrobat.
• Team player with the ability to work independently and coordinate multiple activities simultaneously in support of various studies.
• Excellent attention to detail and strong organizational skills.
• Excellent verbal and written communication and interpersonal skills in English.

Reporting to clinical data management leadership, the Senior Clinical Data Associate shapes all data management aspects of a clinical study from start-up through database lock, independently developing DM documents and leading data cleaning activities with minimal oversight. Partnering with biostatisticians, CROs, Medical Monitors, and cross-functional study team representatives, this senior associate ensures study deliverables meet FDA regulations, ICH GCP guidelines, and corporate quality standards.

Primary Duties

• Lead all data management aspects of a clinical study, including study start-up activities, and guide the study team through change orders and protocol amendments.
• Independently develop DM documents including DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans.
• Utilize templates and standard guidelines to initiate documents, applying critical thinking and discretion to tailor documents to study needs.
• Independently lead data cleaning activities such as study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation.
• Gather cross-functional input to drive creation of custom data review plans and choose efficient issue resolution paths.
• Independently manage data deliverables processes and database locks with high quality and efficiency.
• Foster collaboration and relationship-building with all study team representatives across functional areas.
• Utilize experience and appropriate tools to efficiently lead and coordinate data management activities.
• Ensure study team members understand and deliver components affecting data to ensure successful execution of deliverables.
• Provide solutions for data management issues that arise during study conduct.
• Manage and coordinate work performed by vendors and CROs to ensure quality of product, and assist in vendor selection.
• Run SAS programs, review SAS logs, troubleshoot errors, generate output, and program SAS Non-System Edit Checks and data listings as appropriate.
• Mentor less proficient SAS users as appropriate.
• Evaluate CDM processes and applications for improvements and participate in working groups to develop and implement new processes.
• Coordinate and delegate work performed by junior CDAs and assist in mentoring junior CDAs and contractors.
• Take ownership of process resources available to the team.

Skills & Qualifications

• Bachelor's degree in a relevant field, with years of experience accepted in lieu of education.
• Minimum 4 years of relevant experience.
• Prior experience writing specification documents and work instructions.
• Previous relevant EDC experience.
• Previous vendor and CRO management experience.
• Previous experience with RTSM, IWRS, and ePRO systems.
• Database development experience.
• SAS programming experience; oncology experience preferred.
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, and the drug development process.
• Knowledge and understanding of DM Lifecycle associated with Phase 1 through Phase 3 studies, including pivotal, blinded, and randomized trials.
• SAS programming skills including running programs, reviewing logs, troubleshooting errors, and generating output.
• Proficiency in EDC systems and data management tools.
• Effective organizational and communication skills.
• Demonstrated project management, risk assessment, and time management skills.
• Detail-oriented with a commitment to quality and accurate work.
• Interpersonal skills that encourage collaboration, cooperation, and effective relationship-building.
• Technologically savvy with the ability to quickly pick up new information, standards, tools, and software.

Sitting at the intersection of clinical operations and data governance, the Clinical Data Associate builds and maintains the Data Management Plan throughout each study lifecycle while contributing to eCRF development, data validation specifications, and SAE reconciliation. Operating across internal teams, CRO partners, EDC vendors, and sponsor stakeholders, this associate drives data quality and regulatory alignment across all assigned clinical programs.

Duties

• Contribute to developing and maintaining the Data Management Plan (DMP) throughout the lifecycle of each study project.
• Review and provide input to clinical protocol, Statistical Analysis Plan (SAP), and other documents in collaboration with the biostatistician.
• Contribute to the development of the clinical database, electronic Case Report Forms (eCRFs), and implementation with study teams and EDC vendors.
• Receive and update data transfer agreements (DTA) between external data vendors and core labs.
• Advise study team on data management-related aspects, seek clarification on specific study needs, and provide status updates and issue highlights.
• Contribute to developing and maintaining eCRF Completion Guidelines and work instructions for assigned projects.
• Participate in data review meetings and clinical event adjudication meetings to discuss specific data values relevant to analysis and subject population determination.
• Assist in performing user acceptance testing (UAT) and analysis of testing results.
• Identify and resolve data queries and discrepancies, and contribute to data quality metrics for assigned projects.
• Assist in developing and maintaining Data Validation Specifications, including testing edit checks and ensuring review by relevant team members.
• Act as liaison for internal colleagues, CROs, and other vendors to align on data management timelines and issues.
• Perform accurate review of clinical trial data, including resolution of missing, inconsistent, or clinically questionable data.
• Participate in reconciliation of Serious Adverse Events (SAE) between Clinical and the Database.
• Generate and incorporate study-related metrics for the study team.
• Participate in CRO evaluation to ensure alignment across all clinical programs.
• Liaise with the sponsor and communicate with management regarding all data management activities within assigned studies.
• Participate in business development activities as required.

Experience & Qualifications

• Bachelor's degree preferred or equivalent experience.
• Minimum 2 years of data management experience.
• Experience working with CROs and EDC vendors for data management activities.
• Experience interacting with all levels of management as well as vendors and consultants.
• Adherence to regulatory guidelines, Good Clinical Practice (GCP) Standard Operating Procedures, and client expectations.
• Demonstrated knowledge of medical terminology.
• Knowledge of personal computers, database structures, and database management software.
• Experience with EDC tools.
• Proficient with MS Word, Excel, and Outlook.
• Ability to prepare documents, presentations, and Excel analyses with minimal instruction.
• Strong organizational and communication skills, both verbal and written.
• Demonstrated knowledge of problem-solving techniques including queries and edit checks, and strong analytical skills.
• Highly organized with flexibility and adaptability to manage multiple projects and assignments with a sense of urgency.
• Sound judgment and independent decision-making ability, with the capacity to proceed on own initiative when necessary.
• Ability to handle confidential matters and information with discretion and a security mindset.
• Ability to work independently and as part of a team.

A key member of the clinical research team, the Clinical Data Associate leads data management across multiple complex NIH protocols, overseeing data abstraction from patient records, quality control, and adherence to ICH/GCP standards and Federal Regulations. Collaborating across clinical research teams and cross-functional process initiatives, this associate serves as an internal data management expert whose work directly enables audit readiness and data integrity throughout each assigned study.

Accountabilities

• Adhere to clinical data management project timelines on multiple complex protocols.
• Support data abstraction from patient records and data entry of assigned studies in accordance with SOPs and protocol-specific processes.
• Ensure adherence to project and corporate SOPs, Federal Regulations, and ICH/GCP standards in maintaining data integrity and quality throughout a clinical study.
• Work in a team environment to support eCRF design and end user testing.
• Develop protocol-specific data management plans ensuring alignment with protocol and data quality standards.
• Conduct data quality checks and data reviews.
• Provide data management support in preparation for and response to continuing reviews, monitoring visits, DSMB meetings, and audits.
• Participate in cross-functional process initiatives and clinical research team meetings.
• Abstract and grade adverse events based on protocol specifications and SOPs.

Education & Experience

• Bachelor's degree in Life Science or related field.
• One to two years of experience in data management.
• Experience with clinical trial databases and electronic data capture (EDC).
• Experience with GCP and Human Research Subjects Protection guidelines, as well as regulatory requirements relating to clinical development and compliance with safety, ethical, legal, and regulatory standards.
• Experience with clinical and medical terminology and abstracting data from patient records.
• Knowledge of Federal information technology, the Biotech or Pharmaceutical Industry, or equivalent comparable background.
• Experience with Microsoft Excel for data reporting.
• Strong skills in prioritization, organization, and time management.
• Good communication skills.

On-schedule clinical program advancement depends on the Sr Clinical Data Associate, who ensures data listings are accurate, queries are resolved, and study-level deliverables meet management and client expectations. Based within a global data management function, this associate also acts as subject matter expert for specialized study processes and provides training and direction to junior staff.

Key Deliverables

• Support the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation as required.
• Review data listings for accuracy and consistency of data.
• Act as point person and subject matter expert for specialized study-specific processes.
• Generate, track, and resolve data clarifications and queries, and make changes to the clinical database as required.
• Contribute to the improvement of data management processes on a global level.
• Produce project-specific status reports for management and clients on a regular basis.
• Provide training and work direction to junior staff as required.

Professional Experience

• Bachelor's degree or equivalent formal academic or vocational qualification.
• Up to 2 years of previous experience providing the knowledge, skills, and abilities to perform the job.
• Good written and verbal communication skills with a strong command of the English language and grammar.
• Strong organizational, analytical, and problem-solving skills with attention to detail.
• Ability to apply knowledge and skills in a highly organized manner while adhering to regulatory guidelines, SOPs, and client expectations.
• Ability to work productively with support and minimal supervision.
• Strong customer focus and excellent interpersonal skills.
• Ability to work in a team environment and independently as needed.
• Ability to train and direct junior team members.
• Ability to set and meet timelines and recognize when schedule changes are needed in response to project demands.