Senior Associate

5 days ago

Bengaluru, Karnataka, India beBeeClinicalDataManagement Full time ₹ 9,00,000 - ₹ 12,00,000
Clinical Data Management Associate

Job Description:

  • The Clinical Data Management Associate is responsible for clinical data execution including database structure, content and meaning, acquisition, validation, storage, retrieval, interchange, delivery and representation.

This requires an in-depth understanding of data standards, data collection design, data flow management, data quality, data validation, data review, central coding, data technology, dataset delivery, adjudication coordination, archiving and decommissioning.

The Clinical Data Management Associate will collaborate with stakeholders to define, implement, and deliver clinical data management packages for a trial or set of trials within a program.

Key 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 setup 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 (ie 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

Required Skills and Qualifications:

  • Bachelor's degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
  • 3-7 years of experience in Clinical Data Management activities

Role Overview:

As a Clinical Data Management Associate, you will play a critical role in ensuring the accuracy, integrity, and quality of clinical trial data. You will work closely with cross-functional teams to develop and implement data management plans, manage data flow, and ensure compliance with regulatory requirements.

We offer a dynamic and collaborative environment where you can grow your skills and expertise in Clinical Data Management.

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