01 feb
Sanofi Group
Ciudad de México
Job title: Clinical Study Startup Specialist
- Location: Ciudad de México
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress ._ _Join our Vaccines team as Clinical Study Startup Specialist and you'll be 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 and company SOPs.
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.
About you
- Experience: 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:
- Formal training in GCP methods and knowledge of Code of Federal Regulations (US) and other regulatory agency documents
- 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.
- Education: Bachelor's degree or equivalent in a health-related field, Biology, Life science, Pharmacy.
- 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.
Pursue Progress. Discover Extraordinary.
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. You can be one of those people. Chasing change,
embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
#LI-LAT #LI-HYBRID
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=2s)
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