Provide expert skills as part of a Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs.
Provide leadership to the team and viewed as an expert in data management. Will provide leadership to the team as Data Team Lead (DTL), Data Operations Coordinator (DOC) or Subject Matter Expert for DTLs and / or DOCs.
Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies
Provide leadership to CDM team.
Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.
Provide marketing capabilities presentations and business development presentations.
Serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-
40 central laboratory studies, or serve in a leadership role to a specific DM Task.
Serve as back-up for Data Operations Coordinator or Data Team Lead
Provide leadership to Operations team
Provide technical expertise
Serve as a Subject Matter Expert (SME)
Provide leadership and expertise in a specific CDM task or technology
Manage delivery of projects through full data management process life-cycle.
SOW (scope of work) / budget.
Provide justification for customer negotiations.
May serve as Project Manager for single service data management projects.
Manage comprehensive data management tasks pertaining to the documented project specifications.
Manage comprehensive quality control procedures.
Provide data management expertise and data management process improvement to CDM management.
Mentor other team members in training and developing data management expertise.
Independently bring project solutions to the CDM team and the CDM Department.
Manage a focus team or a best practice team
Manage the development and implementation of new technology / tool.
Present at professional conferences and / or publish articles in professional journals.
Provide CDM with technical expertise.
Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
Perform other duties as directed by the functional manager.
Meet objectives as assigned.
Develop and maintain good communications and working relationships with CDM and project teams.
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 5 years’ experience in clinical trials within a similar function, including proven competence in managing delivery of multiple projects simultaneously through full data management study life-
cycle, including large trials >
1000 patients; and including experience in handling customer negotiations (e.g. bid defence meetings); or equivalent combination of education, training and experience