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Lead Clinical Trial Operations Manager Position 460058

Bridgewater, New Jersey

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Overview

This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

The Lead CTOM is responsible of all operational aspects oversight including delivering every study on time within budget and scope in compliance with GCP’s, SOPs and standards

The Lead CTOM is responsible of the Coordination of internal/external resources and third parties/vendors for the flawless execution of study

The Lead CTOM is involved in the scientific conduct of the study and acts with critical thinking and problem solving mindset

The Lead CTOM is also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. The Lead CTOM must be comfortable working independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders.  The Lead CTOM ensures trial(s) are managed to the highest quality to strive for safety and effectiveness of Sanofi products

The Lead CTOM is assigned to a study having the following criteria:

  • Budget: < 100 MM Euros including internal and external costs
  • #countries/sites:  < 20 (with or without RTM) on one study
  • #vendors/outside CSO interfaces: < 10
  • #TO contributors: < 5 (Lead DM/ DM, CTOM)
  • Cluster of studies role: 1 study
  • Amount of data collected per patient: < 2500

(combination of at least 3 all criteria listed above with some flexibility, and can be in house or fully outsourced studies)

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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