Assistant Clinical Data Manager
Provide comprehensive data management expertise to Clinical Data Management (CDM) to provide efficient, quality data management products that meet customer needs. Provide leadership either in the role of the Data Operations Coordinator (DOC), the role of the Data Team Lead (DTL) or in a leadership role in a specific CDM task (e.g., lead of a task on a megatrial, coder, tester, database designer for technologies that don’t require extensive programming expertise).
• Serve as Data Team Lead (DTL) on multiple global clinical trials or 35+ increasingly complex central laboratory studies.
• Provide leadership to CDM team.
• Manage CDM customer relationship for CDM project team including active participation in DM customer negotiation on timeline, budgetary and other issues (with guidance).
• Provide marketing capabilities presentations and business development presentations.
• Or serve as Data Operations Coordinator (DOC) for one or two global clinical trials with fewer than 20 operations staff (excludes DE) or 20-30 central laboratory studies, or serve in a leadership role to a specific data management task.
• With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead
• Provide leadership to Operations team
• Provide specific CDM task or technology expertise.
• Manage delivery of projects through full data management process life-cycle.
• With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope.
• Provide input for negotiations with customer.
• Provide comprehensive data management expertise (including all operations tasks and creation of project specifications).
• Perform comprehensive quality control procedures.
• Independently bring project solutions to the CDM team.
• Solves issues through using the global issue escalation/communication plan.
• Consult with Standards Group for process issues; communicate ideas for process improvement.
• Assist in developing and implementing new technology.
• Understand and comply with core operating procedures and working instructions.
• Meet objectives as assigned.
• Develop and maintain good communications and working relationships with CDM and project teams.
• Interact with CDM team members to negotiate timelines and responsibilities.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Thorough knowledge of the data management process
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
• Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium Phase III)
• Comprehensive understanding of clinical drug development process
• Excellent organizational, communication, and data management skills (detail oriented)
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
Note: This job description may be filled by the following data management roles (including but not limited to):
• Data Operations Coordinator (DOC)
• Clinical Data Coordinator (CDC)
• Lead Coder
• Coding Reviewer
• Technical Designer (TD)
• Validation Team Lead (VTL)
• Validation Team Member (VTM)
• Data Administrator (DA)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification; with 3 years of related experience including clinical trials experience in a function similar to data management; or equivalent combination of education, training and experience
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time