Clinical Project Assistant
SanofiÂ
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About the Role
Location: India
Job Category: Regulatory Affairs / Clinical Operations
Job Type: Full-Time (Permanent)
About the Role
Indero, a specialized Contract Research Organization (CRO) in dermatology and rheumatology, is seeking a Regulatory Documents Assistant to join its Regulatory Affairs team in India. The successful candidate will play a critical role in establishing, maintaining, and reviewing the Trial Master File (TMF) throughout the life cycle of clinical trials, ensuring document quality and regulatory compliance according to ICH-GCP standards.
This position also involves the setup of Investigator Study File (ISF) binders and collaboration with internal teams to support documentation accuracy, study oversight, and quality control.
Role & Responsibilities
- Participate in the development and maintenance of the TMF structure and the electronic TMF (eTMF) Management Plan.
- File and import essential documents into the TMF, ensuring accuracy and regulatory compliance.
- Conduct regular record reviews of essential documents for completeness, quality, and accuracy.
- Assign metadata and maintain document trackers to support efficient TMF management.
- Set up and execute eTMF quality reviews, addressing findings and ensuring corrective actions.
- Collaborate with Project Assistants and study teams to define expected document lists and resolve TMF issues.
- Receive and review regulatory documents from investigative sites for accuracy and compliance with SOPs.
- Support project managers and coordinators with creation and maintenance of tracking tools and study materials.
- Assist with preparing and coordinating shipments of study supplies to clinical sites as needed.
- Serve as an in-house contact to support Clinical Research Associates (CRAs).
- Perform various administrative and documentation-related tasks to meet project and team objectives.
Educational Qualification
- College degree in a relevant field.
- Knowledge of clinical trial operations and regulatory documentation standards.
Experience & Skills
- Experience in clinical research within the biotechnology, pharmaceutical, or CRO industry.
- Intermediate proficiency in English (French considered an asset).
- Strong computer skills, including Microsoft Word and Excel.
- Exceptional attention to detail and accuracy in documentation.
- Strong organizational skills and ability to prioritize multiple assignments.
- Ability to meet established deadlines and project milestones.
- Versatile, adaptable, and comfortable in a multitasking work environment.
Location
India
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