The Associate Project Data Manager (Assoc PDM) creates and ensures the successful execution of the clinical data management strategy for protocols within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock. Ensures all aspects of the project plan are executed on time and with appropriate quality. Under the guidance of more senior staff, may serve as the lead project data manager or perform a support role for filing programs. Participates in the development of, and ensures adherence to, all clinical data management procedures. Interacts with staff across different sites, countries, and time zones.
Responsibilities include (but are not limited to) :
Develops detailed project plans for the collection, review, and cleaning of all clinical data for protocols within a specific drug / vaccine program. Data include, but are not limited to, case report form (CRF) data, local and vendor transferred lab data, biomarker data, and patient reported outcomes data. Works with other functional areas to coordinate the execution of deliverables culminating in database lock.
Partners with functional area representatives to ensure appropriate use of standards and project-level consistency on database design, collection, review, and cleaning.
Performs risk planning and management, and facilitates cross-functional decision making. If necessary, escalates issues to appropriate levels of management for decision making.
Serves as project manager of all clinical data management activities for protocols as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:
Project planning, schedule development, project initiation, execution, change control, and project 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).
Participation in procurement planning, solicitation preparation, and supplier selection
Management of customer / stakeholder expectations
Identifies and supports improvements to data collection and data management processes and tools.
Knowledge, Skills, and Abilities:
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. Demonstrated ability to use MS Project and formal project management techniques when managing a project.
Strong organization and management skills.
Must be able to communicate effectively-- orally and in written form-- with technical and business area
Education and Work Experience:
B.A. or B.S. degree, preferably in Biology, Chemistry, Computer Science, or related discipline.
At least 4 years' experience in the pharmaceutical / biomedical industry, including at least 1 year of experience in project management.