Group Manager – Clinical Data Management (Remote)
Quanticate
Full time- 9+ years
- Not Disclosed
- Bengaluru, India
- Post Date: Jan 27, 2023
- End Date: Mar 27, 2023
- 9+ years
- Not Disclosed
- Bengaluru, India
- Post Date:Jan 27, 2023
- End Date: Mar 27, 2023
Skills:
- Quality control
- clinical research
- pharmacovigilance
Job Description:
Responsibilities
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Management of allocated personnel:
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Allocation of projects in conjunction with Group Management, as appropriate.
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Performance reviews, as required.
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Administer training and development of personnel, as required.
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Group management for allocated projects
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To oversee and guide with planning and management of study timelines and resources.
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To manage progress against schedules and report to management.
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To perform project management reviews across all functions for a study as appropriate.
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Management of CRFs and all related tasks.
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To contribute to the efficient running of the Clinical Data Management department as part of the Clinical Data Management leadership team.
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To pro-actively keep abreast of current data management developments and systems.
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To mentor data management staff
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To assist in the creation and review of in-house SOPs.
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To research and provide input into in-house strategies and systems.
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To produce a clear breakdown of bookable time for invoicing and ensure the same for direct reports.
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To perform other reasonable tasks as requested by management.
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Ensure launch, delivery, and completion of all Data Management procedures according to contractual agreement and relevant SOPs, guidelines, and regulations.
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Be willing to travel both domestically and internationally as necessary.
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To undertake other ad hoc tasks as required.
Qualification & Experience
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Qualified to an appropriate standard, preferably to degree level in a life sciences subject.
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Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform.
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9+ years of core CDM experience
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Ability to effectively lead project teams across multiple locations.
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Excellent project management skills.
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Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
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Excellent leadership/management skills.
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Salary
Not Disclosed
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Role
Others
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Area of Practice
- Pharmacology/ Pharmacovigilance
- Life Sciences
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Experience
9+ years
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