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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