Sanofi
R&DClinicalTrialSupportManager
“R&D Clinical Trial Support Manager at Sanofi. Skills: Clinical Trial Support, Study Management, Vendor Oversight. Support clinical study leader in execution and delivery. Prepare study related plans and materials”
What You'll Achieve.
execution and delivery of clinical studies; ensure performance expectations are met
Industry & Context.
critical thinking; problem-solving mindset; Ability to anticipate potential issues; proactively identify ways to resolve/mitigate; timely escalate with appropriate action plans; managing issues resolution; proactive mindset
What They're Looking For.
Must Have
Bachelor’s degree, at least 2 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), 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, Good organizational skills, ability to multi-task, skill in establishing priorities and meeting deadlines, Ability to work autonomously, 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
Nice to Have
advanced degree preferred, degree in scientific discipline preferred
What You'll Do.
Support clinical study leader in execution and delivery
Prepare study related plans and materials
Develop study risk management plan
Develop monitoring plan
Develop study communication plan
Develop training material
Develop recruitment plan
Develop retention plan
Develop study operational materials
Review study team-developed documents
Ensure study documentation is maintained and archived
Develop and manage study budget
Track study expenditures
Perform quarterly forecasts
Follow expenses/accruals
Evaluate complementary needs
Perform final budget reconciliation
Organize study specific meetings
Lead study team meetings
Lead meetings with COSCL
Support training of monitoring team
Support investigator meetings
Lead meetings with vendors
Contribute to data cleaning meetings
Contribute to data review meetings
Contribute to RBM meetings
Contribute to data driven monitoring strategy meetings
Oversee vendor activities and deliverables
Ensure vendor performance expectations are met
Track vendor payments
Create clinical sample management plan
Execute clinical sample management plan
Accountable for operational/logistic samples related topics
Monitor samples collection
Monitor samples reception
Monitor samples analysis
Manage issues resolution
Escalate issues as necessary
Document issues resolution
Support IMP needs validation
Support IMP reconciliation process
Participate in audit preparation
Contribute to elaborate proper responses to audit/inspection reports
Develop and implement immediate action plans
Utilize designated tools to oversee quality
How You'll Work.
Team & Collaboration
work with clinical study leader within the same project; collaborate with cross-functional team members; collaborate with external partners; work closely with the translational medicine team; work closely with the clinical development team; collaborate with the different labs vendors
Communication Scope
written communication skills; verbal communication skills; ability to exchange fluently; lead international meetings; write meeting minutes/ emails/ study documents; internal & external communications
Process & Methodology
managing clinical studies, study plan monitoring, risk management, contingency planning, establishing priorities, meeting deadlines
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