Manager, Clinical Data Manager Study Lead

Overview

Lead clinical data management oversight for complex studies within a therapeutic area, serving as the primary point of contact for study teams and external partners, and assist in developing SOPs, working practices, Data Management Plans and other data management standards.

What you'll do

• Serve as the DM study lead and primary point of contact for clinical study teams and external partners (e.g., external data vendors and CROs) for 1 or more complex studies within a given TA.
• Oversee all DM activities across all stages of the trial from study start-up through archiving.
• Provide a high level of expertise in data management to support clinical studies, including clear verbal or written information and hands-on support on eCRF and database design, data quality, and reporting of database / data quality status.
• Oversee the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Manage 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.
• Manage scheduling and time constraints across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.
• Perform and document oversight of CRO data management activities for assigned studies, including design, implementation and maintenance of electronic case report forms, clinical trial database and electronic edit checks according to SOPs and WIs.
• Identify data quality, CRO performance, documentation and process execution gaps and be accountable for resolution.
• Document DM sponsor oversight activities from protocol review through study close-out.
• Review and approve study documentation for assigned studies, including Data Management Plan or equivalent, Case Report Form and Completion Guidelines, and validation and data transfer specifications.
• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance, following through on gaps until resolution and escalating as necessary.
• Lead/oversee all data management deliverables for assigned studies, including deliverable timelines, snapshot/lock plans (in collaboration with the CST), and regular status updates with metrics to the CST.
• Provide program level input to and monitor deliverable timelines.
• Monitor data quality and assess progress of data issue remediation on an ongoing basis.
• Identify risks, propose mitigations, and proactively escalate operational or DM vendor or DM CRO issues.
• May provide limited program level support for a small program with a limited number of studies.

What you'll need

• Bachelor Degree or equivalent experience in Mathematics, Science or a related field.
• At least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry.

Details

• Location: Remote.
• Travel percentage: 25%.
• Many roles are required to be performed on-site; speak with recruiter and hiring manager about on-site expectations for this role and location.