Sanofi US
Clinical Operations Vendor Category Lead (COVCL) Digital
Sanofi US, Cambridge, Massachusetts, us, 02140
Job Title: Clinical Operations Vendor Category Lead, Digital
Location:
Cambridge MA, Morristown, NJ
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.
Overview This role requires a unique blend of clinical operations knowledge, digital transformation expertise, and vendor portfolio management to drive innovation while ensuring operational excellence. The Clinical Operations Vendor Category Lead (COVCL) is fully accountable for the end-to-end operational strategy and delivery of assigned service line vendors to drive operational excellence measured in acceleration of study activities, study optimization, and enhanced quality.
Main Responsibilities
Oversee the end-to-end digital vendor landscape for clinical trials, including Core R&D digital platforms and systems, emerging technology vendors, AI/ML solution providers, digital biomarker strategy, and clinical trial innovation partners.
Collaborate with Digital R&D to align vendor strategies with broader digital transformation initiatives.
Drive MVP evaluations and make data-driven decisions on vendor progression or termination.
Identify opportunities for vendor consolidation and core partner strategy to support key assets.
Thoughtful risk taking on vendor capabilities.
Operational Strategy and Delivery of a Service Line
Oversee vendors performance within the category.
Ensure operational consistency of delivery.
Set service line goals and KPI/QPIs.
Vendor Governance
Organize regular governance meetings for existing vendors.
Participate in selection and qualification of new vendors.
Audit and Inspection Support
Ensure preparation and proper responses to audit/inspection reports for vendor-related findings. Develop and implement immediate action plans with the vendor if needed.
Prepare and assist in PAI preparation and ensure an inspection-readiness approach.
Qualifications
Bachelor’s degree in Health Sciences, Clinical Research, or related discipline.
Minimum 8 years experience in Digital Clinical Operations and/or Clinical Operations Vendor Management.
Experience working with an internal team & strong business acumen.
Significant proven experience in vendor management, vendor oversight, and clinical operations knowledge and managing clinical studies with strong project management skills.
Results oriented, focused on outcomes and demonstrates the ability to think differently and prioritize outcomes.
Solid knowledge of clinical development, GCP & ICH guidelines, regulations by FDA and EMA, and SOPs/QDs.
Strong leadership, decision making, thoughtful risk taking, and problem-solving skills.
Agile and able to deal with frequent changes and unexpected events in clinical studies. Strong ability to act for change.
Strong interpersonal and analytic skills. Excellent written and verbal communication skills. Strong influencing skills to effectively build relationships with internal and external stakeholders. English language skill: fluent in negotiation and international meetings.
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 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.
Equal Opportunity Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmatively 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, marital status, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or 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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Cambridge MA, Morristown, NJ
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.
Overview This role requires a unique blend of clinical operations knowledge, digital transformation expertise, and vendor portfolio management to drive innovation while ensuring operational excellence. The Clinical Operations Vendor Category Lead (COVCL) is fully accountable for the end-to-end operational strategy and delivery of assigned service line vendors to drive operational excellence measured in acceleration of study activities, study optimization, and enhanced quality.
Main Responsibilities
Oversee the end-to-end digital vendor landscape for clinical trials, including Core R&D digital platforms and systems, emerging technology vendors, AI/ML solution providers, digital biomarker strategy, and clinical trial innovation partners.
Collaborate with Digital R&D to align vendor strategies with broader digital transformation initiatives.
Drive MVP evaluations and make data-driven decisions on vendor progression or termination.
Identify opportunities for vendor consolidation and core partner strategy to support key assets.
Thoughtful risk taking on vendor capabilities.
Operational Strategy and Delivery of a Service Line
Oversee vendors performance within the category.
Ensure operational consistency of delivery.
Set service line goals and KPI/QPIs.
Vendor Governance
Organize regular governance meetings for existing vendors.
Participate in selection and qualification of new vendors.
Audit and Inspection Support
Ensure preparation and proper responses to audit/inspection reports for vendor-related findings. Develop and implement immediate action plans with the vendor if needed.
Prepare and assist in PAI preparation and ensure an inspection-readiness approach.
Qualifications
Bachelor’s degree in Health Sciences, Clinical Research, or related discipline.
Minimum 8 years experience in Digital Clinical Operations and/or Clinical Operations Vendor Management.
Experience working with an internal team & strong business acumen.
Significant proven experience in vendor management, vendor oversight, and clinical operations knowledge and managing clinical studies with strong project management skills.
Results oriented, focused on outcomes and demonstrates the ability to think differently and prioritize outcomes.
Solid knowledge of clinical development, GCP & ICH guidelines, regulations by FDA and EMA, and SOPs/QDs.
Strong leadership, decision making, thoughtful risk taking, and problem-solving skills.
Agile and able to deal with frequent changes and unexpected events in clinical studies. Strong ability to act for change.
Strong interpersonal and analytic skills. Excellent written and verbal communication skills. Strong influencing skills to effectively build relationships with internal and external stakeholders. English language skill: fluent in negotiation and international meetings.
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 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.
Equal Opportunity Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmatively 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, marital status, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or 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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