Senior Clinical Data Manager

Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.

Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.

Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.

Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.

Assist with study-level resource planning and management, including the review of team members’ timesheet reports.

Assist in performing client relationship management activities. Participate in project bid defense meeting when required.

Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.

Provide training to new 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, investigators 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.