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 and of information received, 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.
• Coordinates the start-up deliverables of assigned studies in all aspects of start-up (including overall accountability for delivery to time, cost, and quality etc. and communication with relevant stakeholders).
• Develop and implement global study startup project plans and manage the collection and analysis of all data to influence study startup timelines.
• Provide accurate projections and timelines based on country’s historical performance with the support of the CRO partner.
• Monitor start-up activities, identify risks, and manage issues independently, Ensure compliance with local regulatory guidelines and provide support to resolve local issues.Report progress and challenges in trials to the clinical team during team meetings.
• Oversee collection of investigator and regulatory documents for study submissions.
• Support negotiations with sites and maintain quality control of study start-up documents.
• Support negotiations with sites and maintain quality control of study start-up documents.

About You

Education:

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

Knowledge:

• Formal training in GCP methods and knowledge of Code of Federal Regulations (US) and other regulatory agency documents
• Clinical Trial experience required with proven track record in delivering high quality GCP-compliant Clinical Trials and entry level knowledge of vaccinology

Soft and technical skills:

• Demonstrated interpersonal skills (ability to work with individuals at different levels), team and negotiation skills, resourcefulness (ability to find solutions to operational problems),
• strong results orientation, project management and budget management experience.
• Knowledge of epidemiolo and data analys

Languages:

• Fluent English communication skills, verbal and written

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and 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 culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$100,500.00 - $145,166.66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.