Lead Data Manager / Trial Manager- FSP

The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock. Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality. Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents Global Data Management on cross-functional trial teams and in other trial-level development forums.

Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development of, and ensures adherence to, clinical data management procedures. Interacts with staff across multiple sites.

Primary Activities

Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program. Data includes, but is not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.

Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:

Project planning, initiation, execution, change control, and closing.

Project team development, project team leadership, meeting management, and resource coordination.

Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.

Management of customer / stakeholder expectations; facilitation of cross-functional decisions.

Defines trial-level requirements for quality data collection and validation at the trial level.

Reads and interprets the clinical protocol from a clinical data management perspective.

Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.

Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.

Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.

Facilitates assessment and processing of standards and change requests.

Approves trial-level data validation plan (including project and protocol specific data validation elements).

Manages trial-level data quality and completion of database lock and post-database lock activities:

Monitors overall status and quality of data being collected during the in-life portion of a trial.

Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.

Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.

Ensures timely archival of trial data and documentation.

Ensures timely decomissioning of clinical data management technologies.

Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned

Supports site and sponsor audits, as appropriate

Identifies and supports improvements to data collection and data management processes and tools.

Education:B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.

Experience:At least 5-7 years’ experience in Clinical Data Management with at least 1 year experience working with formal project management tools and processes.

Knowledge and Skills:Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle. Familiar and comfortable with database concepts and tools to manage, extract, and report data. Strong organization and management skills. Must be able to communicate effectively — orally and in written form — with technical and business areas.