Job Summary: 

• Assist with the design and development of electronic databases for clinical studies
• Generate daily, weekly, and monthly reports to support the clinical study teams
• Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed, and communicates project status and issues
• Assist in the development of electronic Case Report Forms (eCRFs), eCRF Completion Guidelines (CCGs), and Data Management Plans (DMP)
• Review all clinical data for completeness and accuracy and identify discrepancies
• Work with participating study sites to address any identified issues with data entry
• Collaborate with the project team to address and resolve all data issues
• Review clinical data within studies and across programs for trend analysis
• Identify and implement solutions for clinical data issues or concerns
• Ensure database and data management processes meet project requirements

Skills on Resume:

• Database Design (Hard Skills)
• Report Generation (Hard Skills)
• Stakeholder Collaboration (Soft Skills)
• eCRF Development (Hard Skills)
• Data Review and Accuracy (Hard Skills)
• Site Collaboration (Soft Skills)
• Data Issue Resolution (Hard Skills)
• Trend Analysis (Hard Skills)

Job Summary: 

• Adhere to NIH Clinical Data Management project timelines on multiple complex protocols.
• Support data abstraction from patient records and data entry of assigned studies, gather and enter data in accordance with SOPs and protocol specific processes.
• Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP 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, data safety monitoring board (DSMB) meetings, and audits.
• Participate in cross-functional process initiatives and clinical research team meetings.
• Abstract and grade adverse events based on the protocol specifications and SOPs.
• Assist in clinical protocol development providing input from data management perspective

Skills on Resume:

• Adherence to Timelines (Soft Skills)
• Data Abstraction and Entry (Hard Skills)
• Regulatory Compliance (Hard Skills)
• eCRF Design Support (Hard Skills)
• Data Management Planning (Hard Skills)
• Data Quality Control (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• Protocol Development Input (Soft Skills)

Job Summary: 

• Work collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics, and other cross-functional team members 
• Meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting
• Review study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner
• Identify, track, and resolve routine queries and issues
• Ensure completeness, accuracy, and consistency of routine clinical data and data structure
• Utilize routine reports to track study progress and ensures timeliness and quality expectations are met
• Communicate with members of the FOCUS team to review documents, ask key questions, and collect information
• Input data into an internal data collection system
• Coordinate interviews and information/data collection with FOCUS partners (current and former)
• Prepare for, and present project progress at weekly meetings with FOCUS CDC Evaluation Work Group.
• Act as liaison with CROs, third party data vendors, and EDC vendors

Skills on Resume:

• Cross-Functional Collaboration (Soft Skills)
• Project Management (Soft Skills)
• Protocol Review (Hard Skills)
• Query Resolution (Hard Skills)
• Data Quality Assurance (Hard Skills)
• Progress Tracking (Hard Skills)
• Communication Skills (Soft Skills)
• Vendor Liaison (Soft Skills)

Job Summary: 

• Provides general administrative support to the clinical data management team and the Clinical Operations Department
• Supports Clinical Data Manager(s) and other team members with ongoing conduct of clinical studies
• Assists the data management team in the preparation, handling, distribution, filing, and archiving of study documentation and reports according to the scope of work and standard operating procedures
• Assists with periodic review of study, department, and systems files for accuracy and completeness
• Assists with the preparation of clinical systems validation materials
• Assists with the preparation of clinical data capture training materials
• Assists with review of clinical data according to Data Management Plans and Data Review Plans on assigned projects
• Develop and ensure timely delivery of clinical data reports to project team
• Contact clinical sites or coordinate with clinical team contact sites to facilitate query resolution, missing data, case report form (CRF) signatures, or other needs
• Supports the team with organization and planning of study meetings  

Skills on Resume:

• Administrative Support (Soft Skills)
• Team Assistance (Soft Skills)
• Document Management (Hard Skills)
• Accuracy Review (Hard Skills)
• Systems Validation Preparation (Hard Skills)
• Training Material Development (Hard Skills)
• Data Review (Hard Skills)
• Communication and Coordination (Soft Skills)

Job Summary: 

• Supports the Sponsor data management lead, working closely with and overseeing the progress of DM vendors and CROs.
• Assists with data collection specifications and database build.
• Performs User Acceptance Testing (UAT) on database setup and any mid-study database changes.
• Help oversee data collection and data cleanup process by reviewing data listings and query resolutions.
• Perform data quality review checks and give feedback on data issues to study team.
• Work closely with the Clinical Operations and Biometrics teams to ensure that data collected is of high quality and meets study objectives.
• Help ensure that study team is tracking toward corporate goals for first patient in (FPI) and database lock (DBL).
• Assist with the review of study-specific DM documentation including the Data Management Plan, database specifications, CRF Completion Guidelines and query generation/resolution.
• Support the DM representative in internal meetings. 
• Prepares and distributes project status reports to project team and management 

Skills on Resume:

• Vendor Management (Soft Skills)
• Database Specification (Hard Skills)
• User Acceptance Testing (Hard Skills)
• Data Quality Oversight (Hard Skills)
• Team Collaboration (Soft Skills)
• Goal Tracking (Soft Skills)
• Documentation Review (Hard Skills)
• Status Reporting (Hard Skills)

Job Summary: 

• Performs all aspects of the data cleaning process, with minimal supervision, in accordance with P and SOPsWPDs in order to assess the safety and efficacy of investigational products andor medical devices.
• Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation
• Reviews data listings for accuracy and consistency of data.
• Acts as point person and subject matter expert for specialized study-specific processes.
• Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database 
• Contributes to the improvement of data management processes on a global level.
• Produces project-specific status reports for CDM management andor clients on a regular basis.
• Provides training and work direction to junior staff 
• Attends Proxima company meetings, completes timesheets and documents training

Skills on Resume:

• Data Cleaning Proficiency (Hard Skills)
• Database Design Support (Hard Skills)
• Data Accuracy Review (Hard Skills)
• Subject Matter Expertise (Soft Skills)
• Query Management (Hard Skills)
• Process Improvement (Soft Skills)
• Status Reporting (Hard Skills)
• Training and Leadership (Soft Skills)

Job Summary: 

• Support Lead Data Manager ensuring continuity, responsiveness and completion of tasks in a timely manner
• Review, analyze, validate and maintain clinical trial data to ensure consistency, integrity and accuracy
• Query data inconsistencies and update the databases by understanding standard operating procedures, client guidelines and regulatory agency guidelines
• Perform User Acceptance Testing
• Prepare Patient and Study Level Status/Metric reporting
• Utilize dictionary coding such as MedDRA and WhoDrug
• Generate data retrievals and summaries
• Extract, synthesize, and compile information from multiple data and narrative sources
• Participate in project and cross-functional team meetings
• Assists with maintenance of study tracking tools

Skills on Resume:

• Task Management (Soft Skills)
• Data Validation (Hard Skills)
• Query Resolution (Hard Skills)
• User Acceptance Testing (Hard Skills)
• Metric Reporting (Hard Skills)
• Dictionary Coding (Hard Skills)
• Data Analysis (Hard Skills)
• Cross-functional Collaboration (Soft Skills)

Job Summary: 

• Provide Clinical Data Management support in study start-up, conduct and study close
• Provide supporting services for Clinical Data Management activities including preparing and reviewing documentation, testing clinical systems, and assist EDC team members with tasks
• Perform data review in EDC, query management, database freeze/lock and all related activities Perform reconciliation for external vendor data ensuring data is in alignment with the Data Transfer Agreement
• Communicate with global study teams Coordinate with external vendors to ensure data transfer agreements (DTAs) are approved
• Participate in client study kick-off, closeout and study team meetings
• Prepare specifications for electronic Case Report Forms (eCRFs)
• Prepare Help Text and eCRF Completion Guidelines
• Prepare Data Management Plan (DMP) and Data Validation Specifications
• Prepare User Acceptance Testing (UAT) Plan

Skills on Resume:

• Data Management Support (Hard Skills)
• System Testing (Hard Skills)
• Data Review and Query Management (Hard Skills)
• Vendor Data Reconciliation (Hard Skills)
• Global Team Communication (Soft Skills)
• Meeting Participation (Soft Skills)
• eCRF Specifications (Hard Skills)
• UAT Plan Preparation (Hard Skills)

Job Summary: 

• Oversee and/or perform UAT on the database/user roles/edit check specifications and compile the UAT package
• Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications for overall consistency and accuracy
• Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications using reporting tools
• Oversee and/or perform vendor data reconciliation with applicable clinical database (e.g., IVRS, laboratory data
• Oversee and/or perform query processing/resolution
• Delegate tasks, support and provide guidance to study data management team
• Provide ongoing data management reports and metrics to study teams
• Take ownership of, monitor and ensure adherence to study timelines and deliverables
• Ad hoc report creation and validation

Skills on Resume:

• UAT Management (Hard Skills)
• Data Validation (Hard Skills)
• QC Checks (Hard Skills)
• Data Reconciliation (Hard Skills)
• Query Resolution (Hard Skills)
• Team Leadership (Soft Skills)
• Reporting Skills (Hard Skills)
• Project Management (Soft Skills)

Job Summary: 

• Track data management issues and ensure proper resolution by study completion
• Identify data trends and report study inconsistencies to applicable study team personnel and work together to develop and implement an action plan
• Maintain and compile data management study documentation
• Ongoing evaluation of process and participate in process improvement
• Assist in the creation and review of SOPs and training materials
• Mentor junior level staff and peers on all associated tasks within a study
• Coordinate with the programming team regarding any database or programming changes needed throughout the study if applicable
• Run and review data management metrics reports

Skills on Resume:

• Data Issue Tracking (Hard Skills)
• Trend Analysis and Reporting (Hard Skills)
• Documentation Management (Hard Skills)
• Process Improvement Participation (Soft Skills)
• SOP and Training Material Development (Hard Skills)
• Mentoring Skills (Soft Skills)
• Programming Coordination (Hard Skills)
• Metrics Reporting (Hard Skills)

Job Summary: 

• Assist with the review, cleaning, troubleshooting, and auditing of clinical data and databases in compliance with standard operating procedures, client and study specific guidelines and regulatory agency guidelines.
• Maintain clinical trial data accuracy through review of electronic case report forms (paper and electronic)
• Quality control of data
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback
• Assist in building clinical databases and participate in User Acceptance Testing
• Query data inconsistencies
• Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Patient and Study Level Status/Metric reporting
• Help establish and maintain data management SOPs and working practices.
• Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.

Skills on Resume:

• Data Auditing (Hard Skills)
• Data Accuracy Maintenance (Hard Skills)
• Quality Control (Hard Skills)
• CRF Specification Development (Hard Skills)
• Database Building (Hard Skills)
• User Acceptance Testing (Hard Skills)
• Data Reporting (Hard Skills)
• SOP Development (Soft Skills)

Job Summary: 

• Coordinate and oversee systems, CRO and consultant activities performed for clinical programs as related to data operations activities, including study start-up and closeout processes, data collection, management of timelines, as well as identification and resolution of performance issues on assigned trials
• Ensure clinical trial technical systems (EDC, TMF, CTMS, RTMS, etc.) support trial goals and processes on assigned trials
• Manage clinical trial data or data management projects under aggressive timelines in a high-quality and professional manner. 
• Identify requirements for capture and processing of clinical data ensuring accuracy, consistency and completeness
• Adhering to regulatory standards, SOPs, and work guidelines 
• Provide data in support of the development of protocols, Investigator Brochure(s) and other relevant clinical trial documents
• Coordination and review of protocol deviations for assigned clinical trials
• Ensure compliance with regulations pertaining to data privacy and security measures taken during the collection and storage of clinical trial data from various sources
• Functional representative on project teams, study teams, including multi-disciplinary interactions

Skills on Resume:

• Systems Coordination (Hard Skills)
• Clinical Trial Management (Hard Skills)
• Data Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Problem Resolution (Soft Skills)
• Data Privacy and Security (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• Protocol Deviation Review (Hard Skills)

Job Summary: 

• Statistical programming Program from scratch as well as update existing programs to perform data management, presentation, and analysis. 
• Create Study Data Tabulation Models (SDTM) and Analysis Data Models (ADAM) based on Clinical Data Interchange Standards Consortium (CDISC) for internal and FDA review of trial data. 
• Develop, review, validate, and execute SAS programs to create tables, listings, and figures for company studies to support the demonstration of the safety and efficacy of company therapeutics as defined in the statistical analysis plan. 
• Create and execute macros and program database integrations.
• Data accuracy and integrity Program data cleaning/consistency checking programs to support internal applications for all therapeutic areas. 
• Review data editing and export specifications. 
• Document all programming and validation efforts in accordance with Good Clinical Practices. 
• Create, execute and validate edit check programs. 
• Maintain security of databases and restricted files.

Skills on Resume:

• Statistical Programming (Hard Skills)
• SDTM and ADAM Creation (Hard Skills)
• SAS Programming (Hard Skills)
• Macro Development (Hard Skills)
• Data Validation (Hard Skills)
• Documentation Compliance (Soft Skills)
• Data Security Management (Hard Skills)
• Detail-Oriented Review (Soft Skills)

Job Summary: 

• Perform test transfers to ensure efficient processing of data once received from vendors. 
• Use SDTM guidelines to create and receive transfer datasets. 
• Review and provide input on Statistical Analysis Plans, case report forms, data management plans, and TFL specifications. 
• Participate in user testing of case report forms, databases and other inputs into clinical trial management.
• Quality and standard operating procedures Generate and maintain standard operating procedures (SOPs) for clinical data programming and research tasks. 
• Ensure compliance with SOPs and standards in conduct of research. 
• Participate in development of QC test plans, conventions, specification documents and processes. 
• Maintain a library of reusable code.
• Extract, synthesize, and compile information from multiple data and narrative sources

Skills on Resume:

• Data Transfer Proficiency (Hard Skills)
• SDTM Guidelines Application (Hard Skills)
• Statistical Analysis Review (Hard Skills)
• User Testing Participation (Soft Skills)
• SOP Development (Hard Skills)
• Compliance Assurance (Soft Skills)
• QC Plan Development (Hard Skills)
• Code Library Maintenance (Hard Skills)

Job Summary: 

• Review and organize incoming medical data
• Extract medical data from data files and documents
• Updating and manipulating Electronic Data Capture systems
• Supporting expanding access programs
• Professionally represents Proxima in business interactions
• Assists with maintenance of study tracking tools
• Review and testing Programs and test data export programs. 
• Participate in project and cross-functional team meetings
• Assists with other projects within the company

Skills on Resume:

• Data Management (Hard Skills)
• Data Extraction (Hard Skills)
• Electronic Data Capture Proficiency (Hard Skills)
• Project Coordination (Soft Skills)
• Professional Communication (Soft Skills)
• Tool Maintenance (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• Adaptability (Soft Skills)