Assoc Mgr/Sr. Assoc Mgr (CDM)
Eli Lilly and Company
Full time- 1+ years
- Not Disclosed
- Bengaluru, India
- Post Date: Apr 04, 2024
- End Date: Jun 04, 2024
- 1+ years
- Not Disclosed
- Bengaluru, India
- Post Date:Apr 04, 2024
- End Date: Jun 04, 2024
Skills:
- clinical research
- Clinical Trial
- Management
Job Description:
Responsibilities
- Execute Lilly business requirements for the study/program for vendors to deliver clinical trial data
- Ensure that data management deliverables are delivered to scope, cost, and time objectives
- 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
- Ensure flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
- Contribute to key deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
- Participate in submission, inspection and regulatory response activities
- Central coding activities completed
- Archiving and decommissioning of study related data management documents and content
- Ensure that data acquisition, database design, data validation, data review, central coding and observed dataset requirements are reflective of specific protocol objectives
- Adhere to standards decisions, implementation and compliance for the study/program
- Track and report out key study build, execution and data deliverable metrics
- Help create scope scenarios and negotiate outcomes with study teams while considering the cost and value
- Facilitate the integration of disparate data sources into datasets for decision making
- Utilize therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
- Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
- Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
- Represent Data and Analytics processes in cross-functional initiatives
- Actively participate in shared learning across Data and Analytics organization
Qualification & Experience
- Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
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Salary
Not Disclosed
-
Role
Manager
-
Area of Practice
- Clinical Data Management
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Experience
1+ years
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