Provide comprehensive data management expertise to Data Management 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 DM task (e.g. lead of a task on a megatrial, coder, database
designer for technologies that don't require extensive programming expertise).
Serve as Data Team Lead (DTL) on multiple global studies.
Provide leadership to DM team.
Manage DM customer relationship for DM 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 studies with fewer than 20 operations staff
excludes DE), or serve in a leadership role to a specific DM Task.
With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership
and technical expertise to Operations team.
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
Provide input for negotiations with customer.
Provide comprehensive data management expertise (including all operations tasks and DMP generation).
Perform database designer activities for technologies not requiring extensive programming.
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 team.
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 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 size 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