Associate Director, Clinical Data Management
Associate Director, Clinical Data Management independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. Directs the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, data review, discrepancy management, and database lock. Manages data management staff, Contract Research Organizations (CROs) and service providers' activities in overseeing the data management process life cycle in coordination with internal Biostatistics, Clinical, and Regulatory teams to ensure the accurate, efficient and complete data collection for clinical trials. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Directs the development and maintenance of the components of the study Data Management Plan (DMP). The DMP includes Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review plan, database user requirement specifications, data transfer specifications, and database audit plan. Works with clinical, biostatistics, and regulatory teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP). Directs data management staff and the interaction with contract data management groups to ensure that data management tasks remain on target according to project timelines. Ensures on-going data review are proactively organized throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies. Responsible for ensuring the correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis. . Contributes to and leads the development and implementation of departmental policies, standards and process improvement initiatives. May mentor and develop junior clinical data management staff.
A minimum of a Bachelor's degree in clinical, biological, mathematical sciences or related field, or nursing qualification is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum 10 years pharmaceutical development experience with at least 4 years managing CROs is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 8 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred. Previous people management experience is preferred. Effective problem solving skills. Must have strong computer skills with a proficiency in Microsoft Project, Word and PowerPoint.