Sanofi, a global healthcare leader, is seeking a dedicated Clinical Project Assistant (CPA) to join its dynamic team in Hyderabad, India. This full-time permanent position offers an excellent opportunity to contribute to clinical research and development within an organization known for its commitment to innovative healthcare solutions. Applications for this role are open until December 30, 2024.
About Sanofi
Sanofi Business Operations (SBO) serves as a centralized internal resource organization that supports a variety of business sectors, including Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D. The SBO is designed to foster in-house expertise, enhance efficiency, and reduce dependence on external service providers. With a focus on collaboration and development, Sanofi encourages employees to innovate and contribute to the company’s mission of improving global health.
Key Responsibilities of the Clinical Project Assistant
As a Clinical Project Assistant, your primary responsibilities include:
- Supporting the Registries team with the setup and management of electronic Trial Master Files (eTMF) in adherence to Good Clinical Practices (GCP), protocols, and company SOPs.
- Managing the archiving process by preparing, collecting, reconciling, and filing relevant documents.
- Uploading and performing quality control checks on documents for all sites.
- Providing administrative support for project management activities.
- Coordinating project schedules and tracking milestones in collaboration with the Registries team.
- Assisting with budget tracking and site payments.
- Preparing correspondence and maintaining documentation, such as meeting minutes.
- Overseeing e-training tracking and ensuring compliance.
- Supporting the onboarding process of new project team members.
- Maintaining the Registries SharePoint site and performing other administrative tasks as required.
Qualifications and Skills Required
Experience:
- Minimum of 3 years of experience in clinical research and development, including eTMF document management.
- Familiarity with ICH GCP guidelines and clinical trial methodologies.
Educational Background:
- A bachelor’s degree in life sciences or a related field.
Key Skills:
- Communication: Strong written and oral skills.
- eTMF Management: Proficiency in managing electronic Trial Master Files.
- Attention to Detail: Ensuring accuracy in documentation and task execution.
- Technical Proficiency: Competency with Microsoft Office and familiarity with mobility applications.
- Relationship Management: Effective collaboration with study teams and site staff.
- Confidentiality: Ability to handle sensitive data responsibly.
Language Proficiency:
- High proficiency in written and spoken English.
Soft Skills:
- Collaborative team player with cross-functional coordination skills.
- Methodical approach to prioritizing tasks and meeting deadlines.
