Clinical Project Assistant
SanofiÂ
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Job Description
Category: Clinical Data Coordinator 1
Location: Bangalore, India
Introduction
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Data Coordinator I to join our diverse and dynamic team. As a Clinical Data Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.
Role & Responsibilities
- Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.
- Review clinical and third-party data based on edit specifications and data review plans.
- Issue clear, accurate, and concise queries to investigational sites.
- As required, communicate effectively with peers, clinical data scientist and functional management.
- Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.).
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Educational Qualification
- KNwledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.
- Bachelor’s degree in a relevant field, such as Life Sciences or Healthcare.
- Basic kNwledge of clinical data management within the pharmaceutical or biotechNlogy industry.
- Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar).
- Strong attention to detail and the ability to work effectively in a fast-paced environment.
- Excellent communication skills and the ability to collaborate with cross-functional teams.
- KNwledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.
Location
Bangalore, India
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