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), 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 Lead on multiple global clinical trials or 35+ increasingly complex central laboratory studies.
Provide leadership to CDM and Operations 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.
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.
Solve 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and / or new technology
Knowledge of operating procedures and work instructions and the ability to apply them in practice
Excellent experience and organizational, communication, and demonstrated expert data management skills
Comprehensive understanding of clinical drug development process (detail oriented)
Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 2 - 3 years’ related experience in a function similar to data management : or equivalent combination of education, training and experience