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Associate Director, Clinical DataManagement

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

Manage a Functional Department of Data Management staff. Size of team could vary from 15-40, and may be a first-lineor second-line management position. Define and prioritize resource requirements and manage resource assignments across projects. Monitor and manage utilization and productivity of Functional Department. Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates anddocuments performance. Define recruiting strategies and staffing needs based on hard backlog. Define and implement department objectives consistent with broader office company objectives. Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF (case reportform), database design and set-up, validation definition and programming, Data Management Plan and databasedeliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Monitor quality and efficiency across projects to identify trends and opportunities for improvements. Ensure sharing oflearning across projects. Participate in defining strategies for new processes and technology at either regional or global level. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope ofwork. Define and implement training/professional development strategy for Functional Department. Mentor staff members to develop Data Management process, system, and drug development expertise. Manage relationship with customer at both the project team level and with functional peers. Provide operational input into proposals and scope of work. Participate in proposal defenses. Provide input to costingalgorithms, particularly at the customer level. Attend customer meetings and lead discussions of project requirements and strategic planning. Ensure compliance of work with project s scope of work. Actively assess and help manage project realization. Ensure project milestones are met according to agreed upon timelines with high quality. May serve as a Data Management Customer Liaison for one or more customers. Manage staff in accordance with organizations policies and applicable regulations. Responsibilities include planning,assigning, and directing work; appraising performance and guiding professional development; rewarding and discipliningemployees; addressing employee relations issues and resolving problems. Approve actions on human resourcesmatters.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 Technical programming skills Outstanding written and oral communication skills Proven leadership skills Outstanding problem solving skills Excellent interpersonal skills Excellent organizational skills and demonstrated ability to delegate appropriately Ability to establish and maintain effective working relationships with coworkers, managers and clients QualificationsMINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelors degree, or educational equivalence, in clinical, biological or mathematical sciences or related field, or nursingqualification with 10 years of relevant work experience including substantial people management experience; orequivalent combination of education, training and experiencePHYSICIAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers.
Degree: MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 10-15


Admin Services/Medical Facilities | Medical Superintendent/Director | Regulatory Affairs
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