Assoc Mgr/Sr. Assoc Mgr

2 months ago

Bengaluru, India Lilly Full time
We’re looking for people who are determined to make life better for people around the world.
Purpose:
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 (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
Project Management
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
Enterprise Leadership
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
Minimum Qualification Requirements:
Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
Job is located in Bangalore, India
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly

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