Clinical Data Manager
Eli Lilly and Company
Full time- 3+ years
- Not Disclosed
- Bengaluru, India
- Post Date: Jan 23, 2023
- End Date: Mar 23, 2023
- 3+ years
- Not Disclosed
- Bengaluru, India
- Post Date:Jan 23, 2023
- End Date: Mar 23, 2023
Skills:
- pharma
- clinical research
- pharmacovigilance
Job Description:
Responsibilities
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Execute Lilly business requirements for the study/program for vendors to deliver clinical trial data
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Ensure that data management deliverables are delivered to scope, cost, and time objectives
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Coordinate end-to-end data management activities – from study set up through trial execution through dataset delivery, including on time delivery of a quality, locked database
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Ensure flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
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Contribute to key deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
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Participate in submission, inspection and regulatory response activities
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Central coding activities completed
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Archiving and decommissioning of study related data management documents and content
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Ensure that data acquisition, database design, data validation, data review, central coding and observed dataset requirements are reflective of specific protocol objectives
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Adhere to standards decisions, implementation and compliance for the study/program
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Track and report out key study build, execution and data deliverable metrics
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Help create scope scenarios and negotiate outcomes with study teams while considering the cost and value
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Facilitate the integration of disparate data sources into datasets for decision making
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Utilize therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
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Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
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Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
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Represent Data and Analytics processes in cross-functional initiatives
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Actively participate in shared learning across Data and Analytics organization
Qualification & Experience
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3 years Data Management experience or 5 years experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)
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Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, Business
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Salary
Not Disclosed
-
Role
Others
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Area of Practice
- Pharmacology/ Pharmacovigilance
- Life Sciences
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Experience
3+ years
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