SR. CLINICAL DATA MANAGER

Data Management Study LeadServe 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.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.