Sanofi, a global healthcare leader, is committed to building a healthier and more resilient world. Through innovative medicines and vaccines, Sanofi works tirelessly to make the impossible possible, transforming the lives of millions around the world. The company’s vision is rooted in scientific excellence, and it continues to explore new ways to address unmet medical needs across the globe.
Responsibilities of a Clinical Trial Support Manager at Sanofi
As a Clinical Trial Support Manager (CTSM) at Sanofi, you will play a critical role in supporting the Clinical Study Leader (CSL) in the execution and delivery of clinical studies. You will be responsible for a wide range of activities including the preparation of study-related documents, managing study risks, monitoring the study plan, and supporting the study leader in budget tracking and invoice approval. Some of the key responsibilities include:
- Study Documentation & Planning: Contributing to the creation and development of various study-related documents such as the Study Risk Management Plan (SRMP), Monitoring Plan (MP), Study Communication Plan, and training materials.
- Budget Management: Assisting in the preparation of the study budget and supporting the tracking of expenditures, forecasts, and vendor reconciliations.
- Study Meetings & Communication: Organizing and leading study team meetings, overseeing communication with Clinical Operations Study Country Leads (COSCL), and coordinating meetings with external vendors.
- Vendor Management: Monitoring and ensuring that all outsourced vendor activities meet performance expectations, including budget tracking and payments.
- Sample Management: Working closely with the translational medicine team to manage clinical sample logistics, tracking, and issue resolution.
- Data Review: Supporting data cleaning, data review, and monitoring activities for data-driven decision-making.
Qualifications for the Clinical Trial Support Manager Role
To be successful in the role of Clinical Trial Support Manager at Sanofi, candidates should meet the following qualifications:
- Educational Background: A Bachelor’s degree is required, with an advanced degree in a scientific discipline being preferred.
- Experience: Previous experience in clinical operations and managing clinical studies is essential. Basic knowledge of clinical development, GCP & ICH guidelines, as well as regulations by major regulatory bodies like the FDA and EMA is required.
- Additional Skills: A good understanding of clinical research processes, the ability to work collaboratively with cross-functional teams, and strong organizational and time-management skills. Candidates should also be able to anticipate potential issues, proactively resolve challenges, and adapt to new technologies.
Key Skills for Success
In addition to the necessary educational qualifications and experience, the ideal candidate should possess the following skills:
- Collaboration & Communication: Ability to work effectively with the Clinical Study Leader and other project team members, using strong communication and negotiation skills.
- Problem-Solving: Demonstrated ability to identify issues early and develop proactive solutions.
- Adaptability: Comfortable adapting to changing environments, technologies, and processes, especially with the introduction of new digital tools.
- Organizational Skills: A well-organized individual who can manage multiple tasks, prioritize effectively, and meet deadlines autonomously.
How to Apply for the Clinical Trial Support Manager Position
If you are passionate about advancing clinical research and believe you have the qualifications and skills for the Clinical Trial Support Manager role, you can apply directly through Sanofi’s career portal. The position is based in Hyderabad, India, and the application deadline is January 31, 2025.
