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Job Title: eCOA Clinical Operations Vendor Category Lead-

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. 

Join our Vendor Performance Management Team as a E-Clinical Outcome Assessment Vendor Category Lead to drive excellence in patient-centered clinical research through effective implementation of electronic Clinical Outcome Assessment (eCOA) solutions. This role combines scientific expertise with operational excellence to ensure successful execution of eCOA initiatives across our clinical development programs.

The Clinical Operations Vendor Category Lead (COVCL) is fully accountable for the end-to-end operational strategy and delivery of their assigned service line / vendors performance to drive operational excellence measured in acceleration of study activities, study optimization, and enhanced quality.   Create a working environment that encourages high vendor operational performance and innovation.

General Information on the Role: The COVCL will oversee each SPM (Supplier Performance Management) within the category to ensure operational consistency, on time and high-quality delivery.  This role will identify optimization and opportunities to simplify processes to support the pace & delivery of the development portfolio.  They will set service line goals, KPIs and target metrics and measure the success with each vendor.  

The COVCL will encourage innovation and bring new best in class ideas and approaches to the table for developing and executing category strategies and working within the supply market to opportunities meets or exceed innovation objectives.

The COVCL will be well versed in Sanofi’s portfolio, corporate KPIs and will work with the study teams managing those KPIs/QPIs to ensure vendor support and delivery as expected.  The COVCL will have a strong understanding of the number of planned studies, vendor capabilities and indications to be able to assess potential workload, lessons learned and cost savings with the vendors.

The COVCL will have a deep understanding of the vendor’s processes, operational model and timelines for implementation to identify and support continuous improvements and lessons learned.  They will identify areas of risk and outline mitigation plans. 

They will understand the end-to-end contracting process and ensure the vendor is within the obligations. Have a clear vision of category spend and efficiencies.    

The COVCL will be responsible for initiating, maintaining, and delivering strong governance in their given categories/services.  They will partner with procurement and quality and contribute to the internal outsourcing governance to set/adjust the strategy of the given services/categories under his/her responsibility. 

COVCL will be involved in new vendor selection and qualification and will be aware of the current trends and competitive landscape of their service.

The COVCL will ensure quality of the delivery of the service line by supporting audits at both the study and vendor level. 

The COVCL will need to utilize change management techniques to drive the development and utilization of new ways of working to empower vendor success.

Key interfaces for COVCL are the of vendors, Vendor Excellence SMEs, Clinical Operations Project Lead, Clinical Operations Study Lead, Procurement and other relevant departments.

COVCL functionally reports to Vendor Performance Management Head.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Lead planning, execution, and management of eCOA implementation across clinical trials

• Drive operational excellence in eCOA study execution from setup through data integration

• Manage vendor relationships and coordinate cross-functional study teams

• Identify and implement best solutions for operational challenges in eCOA implementation

• Oversee project tracking and ensure data quality and timeline adherence

• Serve as subject matter expert for eCOA operational best practices & data integration

• Lead project meetings and issue resolution

• Support proposal development and budget management

• Ensure compliance with Sanofi SOPs and quality standards

End to End 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

Strong Vendor Governance:

• Organize regular governance meetings for existing vendors.

• Participate in selection and qualification of new vendors.  

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• Support study and vendor audits/inspections: Ensure preparation and proper responses to audit/inspection reports for finding associated to 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.

About You

Required Qualifications:

• Bachelors degree in relevant field (Health Sciences, Clinical Research, or related discipline)

• Minimum 8 years experience in Clinical Outcome Assessment or eClinical operations

• Demonstrated experience in eCOA study operations

• Practical knowledge of eCOA setup, oversight, and data integration

• Experience managing vendors and coordinating cross-functional study teams

• Understanding of clinical data workflow and data integration processes

Technical Expertise:

• Proficiency in eCOA implementation and operations

• Knowledge of clinical trial regulations and GCP

• Understanding of system development lifecycle methodology

• Experience with clinical data management systems

• Strong technical understanding of data integration processes

• Expertise in identifying and resolving operational inefficiencies

Skills/Knowledge

• Solid 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.

• Strong in leadership (ability to interface with all Sr. levels across the organization), decision making, thoughtful risking taking and problem-solving skills. Strong critical thinking skills;able to identify and anticipate study risks.

• Agile and able to deal with frequent changes, delays or 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: ability to exchange fluently (incl. negotiation), lead international meetings, analytics ability to dive into data driving operational delivery, write meeting minutes/ emails/ study documents, internal & external communications.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discovery Extraordinary.

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