Lilly Clinical Data Manager in Bengaluru, India
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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
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
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
Other Information/Additional Preferences:
3 years Data Management experience or 5 years experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)
Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, Business
Experience with the following:
Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
Deciding the technology platform (system/database) for data acquisition and aggregation
Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
Strong therapeutic/scientific knowledge in the field of research
Society of Clinical Data Management certification
Project management experience
Vendor management experience
Familiarity with clinical data tools and technologies
Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle, programming, analytical tools)
Experience in forms design and layout
Understanding and experience in using data standards
Experience with designing and handling of eCOA data
Knowledge of medical terminology
Domestic and International travel may be required
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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