DUTIES:
• Serve as the DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for multiple trials within a given TA.
• Lead all aspects of all DM activities across all stages of the trial from study start-up through archiving. Accountable for providing comprehensive program level oversight of SDMs to ensure consistency and compliance of program level standards, track milestones/deliverables, escalate and follow to resolution and communicate program level updates to SDMs
• Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
• Interact cross-functionally and provide project leadership for SDMs within the program
• Collaborate with data management peers and other cross functional stakeholders to define and develop operational type of reports to assist with data exploration and metrics.
• Perform & document the oversight of CRO data management activities for assigned studies.
• Data Management Plan (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non-CRF data
• Lead data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding. • Support the transfer, locking, and archiving of study databases. Lead scheduling and time constrains across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow. • Ensure the eTMF documentation is maintained on a regular basis for assigned studies
• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance
• Own the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Ensure and manage clinical data are processed according to Good Clinical Practices (GCP), Standard Operating Procedures (SOPs) and Data Handling Guidelines

REQUIREMENTS:

• Master's degree Health Administration, Pharmacy or related discipline
• 24 months experience
• Must also have experience with at least one of the following areas/technologies also required: ECS, TMF, CCG, UAT, CRF Specification, QC, DTA/DT

Posted On: 5/21/2026