R&D Clinical Trial Support Manager

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Skills you'll use

What you'll do

• Ensure proper study documentation/availability, Develop / contribute with study team members all required study documents as per SOP including but not limited to the Study Risk Management Plan (SRMP), Monitoring Plan (MP), Study Communication Plan, Training Material, recruitment and retention plan, Who’s who and study operational materials including memos, study newsletters
• Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF (Case Report Form) and completion guidelines, Centralized Monitoring Plan, committee charters and/or other operational documents as requested to provide operational input.Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant Sharepoint locations as required.

Who can apply

• Bachelor’s degree (advanced degree preferred, degree in scientific discipline preferred) and at least 6 to 8 years of experience in clinical operations and managing clinical studies
• Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs.
• Demonstrated ability to work efficiently with clinical study leader within the same project, ability to collaborate with cross-functional team members and external partners using collaborative negotiation skills
• Ability to anticipate potential issues, proactively identify ways to resolve/mitigate, timely escalate with appropriate action plans Readily adapt to new environment, technologies and processes (e.g. new digital tools)
• Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines
• Ability to work autonomously, Strong written and verbal communication skills.
• English language skill: ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents, internal & external communications.
• 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, gender identity or Veteran status.

About Sanofi

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