Job Title:Clinical Study Start Up Specialist- Vaccines

Location: Swiftwater, PA

About the Job

Join our Clinical Study Management Team as a Clinical Study Start-up Specialist (C3S). In this key role, you'll represent and support the Global Clinical Department at the study level, collaborating with all functions in Clinical to optimize deliverables.

The C3S is responsible for managing clinical studies within Sanofi Vaccines R\&D. They assist in feasibility and study start-up across all trial regions, ensuring quality deliverables, adherence to protocols, and compliance with Good Clinical Practice (GCP) and company SOPs.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Partner with Clinical Research Organizations (CROs), Clinical Operations teams, and Feasibility partners to improve overall study startup metrics and implement processes.
Coordinate the start-up deliverables of assigned studies, ensuring timely, cost-effective, and quality delivery, and communicate with relevant stakeholders.
Develop and implement global study startup project plans and manage data collection and analysis to influence timelines.
Provide accurate projections and timelines based on historical performance with CRO support.
Monitor start-up activities, identify risks, manage issues independently, ensure compliance with local regulations, and support resolution of local issues. Report progress and challenges during team meetings.
Oversee collection of investigator and regulatory documents for study submissions.
Support negotiations with sites and maintain quality control of start-up documents.

About You

Education:

Bachelor's degree or equivalent in a health-related field (Biology, Life sciences, Pharmacy)

Knowledge:

Formal training in GCP methods and knowledge of CFR (US) and other regulatory documents.
Clinical Trial experience with a proven track record in delivering high-quality GCP-compliant trials; entry-level knowledge of vaccinology is a plus.

Soft and Technical Skills:

Interpersonal skills to work effectively with individuals at different levels, team and negotiation skills, resourcefulness in operational problem-solving.
Results-oriented with project and budget management experience.
Knowledge of epidemiology and data analysis.

Languages:

Fluent in English, verbal and written.

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.
Opportunities for growth and career development, locally or internationally.
Competitive rewards package recognizing your contributions.
Comprehensive health and wellbeing benefits, including high-quality healthcare, wellness programs, and at least 14 weeks' gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a diverse workforce. All qualified applicants will receive consideration without regard to various protected characteristics.

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Compensation will be based on experience. Employees may participate in benefit programs; more information here.

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Clinical Study Start Up Specialist- Vaccines