Posted 20 days ago
Clinical Data Manager II
AI Summary
Manages clinical study data end-to-end, designing databases and CRFs, ensuring data accuracy and regulatory compliance, and supporting study teams with data extracts and reporting.
About this role
We’re on a mission to change the future of
clinical research. At Perceptive, we help the
biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but to do this, we need people like you.
Apart from job satisfaction, we can offer you:
HEALTH:
- Medical plan for you and your dependents.
- Personal Accident Insurance
- Life Insurance
- Critical illness cover
WEALTH:
- Salary structure and Flexi basket
- Provident fund of 12%
- Gratuity scheme
YOURSELF: Internal growth and development programs & trainings
The Clinical Data Manager II is an end-to-end data custodian and plays a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. The Clinical Data Manager excels in defining overall data standards, data collection requirements, data import, extraction, reporting, and analysis methods. The incumbent shall demonstrate a strong working knowledge of Good Clinical Data Management Practices.
Key Responsibilities:
Primary
The Clinical Data Manager II plays an essential role in the efficient design of project databases, the integration of data from multiple sources, and the reporting and analysis of key study data metrics. The incumbent will recommend and drive solutions for database design and data reporting. This role is critical for meeting sponsor study data endpoints and requirements.
Design study CRFs and databases utilizing eCRF library
Create study Data Management Plan and deployment roadmap
Monitor study timelines and communicate risk
Develop database edits, rules, and derivations
Prepare tracking reports and metrics
Facilitate study team involvement in database development
Prepare data extracts and processing for sponsor deliverables
Communicate with sponsors regarding study data processes, endpoints, and overall data management process
Other
Carryout any other reasonable duties as requested.
Functional Competencies (Technical knowledge/Skills)
Technical project management and oversight
Task creation and tracking via ticketing software
Proficient with clinical data management systems
Experience working with research support or clinical team
Experience, Education, and Certifications
Bachelor’s Degree in Life Science (Biology, Medical Technology, Research Psychology, Math or Health Science or equivalent experience in a related field
5-7 years practical work experience in a clinical or technical setting
Demonstrated experience in team settings to achieve goals
Demonstrated experience with clinical data management systems
Experience working with research support or clinical team
English: Fluent
Come as you are.
We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Skills
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