Lead Clinical Data Manager – Study Data & CRO Lead

ALTEN; King of Prussia (PA); On-site; USD 110,000 - 150,000; Full time

Job description

Responsibilities

• 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 therapeutic area.
• Lead all aspects of DM activities across all stages of the trial from study start‑up through archiving, providing comprehensive program‑level oversight of SDMs to ensure consistency and compliance with program standards, tracking milestones and deliverables, escalating issues, and communicating updates to SDMs.
• Provide clear verbal or written information and hands‑on support to project team members and CROs regarding 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 reports to assist with data exploration and metrics.
• Perform and document the oversight of CRO data‑management activities for assigned studies.
• Execute the Data Management Plan, including Data Review, Reconciliation and Cleaning, Coding, SAE Recon, and 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, and lead scheduling and time constraints across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.
• Ensure the eTMF documentation is maintained regularly 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 in Health Administration, Pharmacy, or a related discipline.
• At least 24 months of relevant experience.
• Experience with at least one of the following areas/technologies (ECS, TMF, CCG, UAT, CRF Specification, QC, DTA/DT).