Associate – Regulatory Affairs
CLINCHOICE
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Job Description
Full Time | Entry-Level | Hybrid Work
Location: Hyderabad, India
Requisition ID: R-038994
Date Posted: October 28, 2025
About the Role
As an Analyst 1 within the R&D Operations – Clinical Trial Project Management function, you will provide essential support for the planning, execution, and monitoring of clinical trial operations. This entry-level role offers hands-on exposure to the clinical research environment, allowing you to contribute to the smooth execution of studies and ensure data integrity throughout the trial lifecycle.
Role & Responsibilities
- Support clinical trial project management operations under close supervision.
- Conduct basic research and data collection for clinical trials from initiation to completion.
- Assist in the development, editing, and organization of study-related materials such as informed consent forms, protocols, and site reference guides.
- Arrange and coordinate training workshops and prepare study materials for staff and stakeholders.
- Monitor and analyze key aspects of ongoing trials to identify discrepancies and support issue resolution.
- Compile routine reports, dashboards, and documentation to assist the Clinical Trial Project Management team in tracking study progress.
- Provide on-site visit support, sharing basic project information with clients and stakeholders as needed.
- Support day-to-day study operations, escalating any issues, complaints, or risks to management.
- Adhere to Johnson & Johnson’s Credo and Leadership Imperatives in all team interactions.
Educational Qualification
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline.
- 0–2 years of experience in clinical research operations or project management (fresh graduates are encouraged to apply).
- Basic understanding of clinical trial processes and regulatory requirements (ICH-GCP preferred).
- Strong organizational, analytical, and problem-solving abilities.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office tools (Excel, PowerPoint, Word).
- Ability to work collaboratively in a hybrid, cross-functional environment.
Location
Hyderabad, India
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