Principal​/Sr CDM

Key Accountabilities

• Lead Data Management Activities, Perform Training and Client Relationship Management
• Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
• Serve as the primary contact person for day-to-day data management activities, and be ultimately responsible for all data management deliverables for assigned projects.
• Act as the primary contact for communication and discussion of topics related to data management timelines and deliverables; request out-of-scope tasks; serve as first line contact for technical or procedural issues.
• Plan and implement data management timelines and deliverables; provide database and data management activities status reports; contribute to overall project planning, progress tracking and reporting.
• Assist with study-level resource planning and management, including reviewing team members’ timesheet reports.
• Perform client relationship management activities. Participate in project bid defense meeting when required.
• Provide training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
• Provide training to recent data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
• Assist in generation of project Work Orders and Amendments.
• Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
• Participate in project kick‑off meeting, investigator meeting, and regular project management team meeting.
• Provide support to client audits and regulatory inspections. Follow up on audit findings.
• Create and maintain clinical trial Data Management Study Binders.

• Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
• Design and review Clinical Trial Source Document templates and completion instructions when required.
• Develop and maintain data validation specifications.
• Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.
• Participate in the database design process. Participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT).
• Manage the process of database modifications (after go‑live) due to protocol amendments or study needs.
• Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
• Perform Third Party non‑CRF data management activities.
• Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
• Perform Serious Adverse Event reconciliation.
• Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
• Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.
• Perform database soft‑lock and hard‑lock activities.
• Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.

• A Bachelor’s or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
• At least 7 years of experience in pharmaceutical clinical trial data management.
• Demonstrated in-depth understanding of clinical trial data management concepts, processes and procedures, and relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards.
• Demonstrated strong leadership in clinical data management activities and a desire to excel in leading data management projects.