Associate / Senior Associate - CDS

The Clinical Data Management Associate is responsible for trial level 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 the Clinical Data Associate, Clinical Study Build Programming Associate, Clinical Data Analytics Associate and key study stakeholders to define, implement, and deliver clinical data management packages for a trial or set of trials within a program.

Primary Responsibilities :  This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Portfolio Strategy, Planning and Delivery

• 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 (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

Project Management

Enterprise Leadership

Minimum Qualification Requirements :

Role :   Business Analyst

Industry Type :   Pharmaceutical & Life Sciences

Department :   Data Science & Analytics

Employment Type :   Full Time, Permanent

Role Category :   Business Intelligence & Analytics

Education

UG :   Any Graduate

PG :   Any Postgraduate

Skills Required

Coding, Project Management, Data Collection