Clinical Data Management Specialist
5 days ago
We are seeking a skilled Clinical Data Management Specialist to join our team at Lilly. As a key member of our Clinical Data Management team, you will play a crucial role in ensuring the quality and integrity of clinical data for our trials.
Key Responsibilities:Execute Lilly business requirements for study/program 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.
To be successful in this role, you will need:
- Bachelor's degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy.
- Job is located in Bangalore, India.
The estimated annual salary for this position is ₹900,000 - ₹1,200,000 depending on experience and qualifications.
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