Manager, Clin Data Mgmt
2 weeks ago
**JOB RESPONSIBILITIES**
- Manage a team of professional Data Management staff. Size of team could vary from 5+ upwards -15, depending on the Data Management Function
- Define and prioritize resource requirements and manage resource assignments across projects
- Directly responsible for utilization of staff
- Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates and documents performance
- Propose salaries, promotion and termination actions
- Actively contribute to recruitment of new staff
- Implementation of department/office objectives
- Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers
- Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency
- Participate in the development and implementation of new processes and technology
- Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work
- Identify and address professional development/training needs of staff
- Mentor staff members to develop Data Management process, system, and drug development expertise
- Provide operational input into proposals and scope of work. Participate in proposal defenses
- Attend customer meetings and lead discussions of project requirements and strategic planning
- Understand scope of work, budget, and scope assumptions
- Identify out-of-scope work and provide revised costs with supporting documentation
- Ensure project milestones are met according to agreed timelines. Actively manage quality throughout project
- May be Project Manager/Project Lead for a major study or a series/group of studies
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
- Advanced knowledge of Data Management processes and systems - Solid understanding of clinical drug development process
- Excellent written and oral communication skills
- Proven leadership skills - Excellent organizational skills and demonstrated ability to manage projects
- Effective problem-solving skills - 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, with a minimum of 7 years of relevant work experience including people management; or equivalent combination of education, training and experience
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