Sanofi, a global healthcare leader, is inviting applications for the role of Clinical Project Assistant (CPA) in Hyderabad, India. This full-time permanent position offers an excellent opportunity to contribute to cutting-edge clinical research. Let’s explore the details of the role and why you should consider joining this renowned organization.
Company Introduction
Sanofi Business Operations (SBO) is a pivotal internal organization within Sanofi, designed to centralize processes and support various business units, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. SBO focuses on reducing dependency on external service providers while nurturing internal talent. By joining Sanofi, you’ll be part of a diverse and inclusive team that champions innovation and collaboration.
Responsibilities in the Job
As a Clinical Project Assistant, you will play a key role in supporting registry studies and ensuring smooth project execution. Your main responsibilities will include:
- Managing and administering electronic Trial Master File (eTMF).
- Archiving, collecting, reconciling, and filing relevant documents.
- Ensuring timely updates of project milestones and collaborating with the Registries team.
- Providing administrative support, including project budget tracking, site payments, and meeting coordination.
- Overseeing the quality control of uploaded documents and ensuring compliance with regulatory standards.
- Supporting project audits, onboarding new team members, and maintaining Registries SharePoint.
- Ensuring the Trial Master File is inspection-ready at all times.
Qualifications and Experience
The ideal candidate should meet the following criteria:
- Education: Bachelor’s degree in Life Sciences or a related field.
- Experience: At least 3 years in clinical research, with hands-on experience in eTMF management.
- Regulatory Knowledge: Solid understanding of ICH-GCP guidelines and clinical trial methodologies.
- Language Proficiency: Excellent written and spoken English skills.
Skills Required
To excel in this role, you should possess:
- Strong attention to detail and organizational skills.
- Proficiency in Microsoft Office and the ability to work with emerging technologies.
- Effective communication and collaboration skills to engage with diverse stakeholders.
- Ability to maintain data confidentiality and comply with regulatory standards.
