Job Description – Mgr, CDM (1512531):
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Manage and support team of Data Management professionals to efficiently produce databases that meet customer
• 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
• 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
• 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 upon 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
All responsibilities are essential job functions unless noted as nonessential (N).
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 coworkers, 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 a minimum of 7 years of relevant work experience including people management; or equivalent
combination of education, training and experience
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
Primary Location: India
Organization: IND02 – India – CDS/Product Devel
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