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Lead Clinical Trial Operations Manager

Cambridge, Massachusetts

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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 Clinical Trial Operations Manager (Lead CTOM) is responsible for all operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP’s, SOPs and standards.

  • The Lead CTOM is responsible for the coordination of internal/external resources and third parties/vendors for the flawless execution of the study.
  • The Lead CTOM is involved in the scientific conduct of the study and acts with a critical thinking and problem-solving mindset.

This role 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. You 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 the safety and effectiveness of Sanofi products.

Responsibilities

  • Provide oversight of a study to ensure progress according to study timelines.
  • Ensure proper documentation availability.
  • Ensure proper collection and validation of data and documentation in a timely manner.
  • Organize and lead study-specific meetings.
  • Collect, synthesize and report study information.
  • Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Products (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process.
  • Participate in the selection and management of vendors, development/follow-up of the associated budget.
  • Preparation and oversight of study audits/inspections both internal and external.
  • Provide oversight and preparation for FDA pre-approval inspections (PAI).
  • Participate in the training of new CTOMs on therapeutic areas and general responsibilities within their function.

    Required Education/Experience

  • Bachelor's degree
  • At least 3 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 2 years of clinical research experience). 
  • 1+ year of prior project management and/or supervisory experience in coordinating international clinical trials is strongly required.

Preferred Education/Experience

  • Advanced Degree in scientific discipline Or equivalent RN preferred.
  • 4 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 3 years of clinical research).
  • At least 2+ years of prior management and/or supervisory experience in coordinating international clinical trials is preferred.
  • Ability to lead the study team and efficiently work with other CTOMs in the same study.
  • Ability to manage and lead international meetings (e.g. Study Teams).
  • Ability to anticipate, timely escalate issues and define appropriate action plans.
  • Ability to lead transversal projects.
  • Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot).
  • Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team).
  • Demonstrate stakeholder management skills (e.g. ability to manage expectations).
  • Good Project Management expertise.
  • Good organizational skills including attention to detail and multi-tasking skills.
  • Ability to develop and maintain an optimized study planning with other functions (including identification of critical path).
  • Ability to coordinate multiple interfaces, both internally and externally.
  • Ability to work autonomously to efficiently and effectively provide status reports.
  • Capability to routinely perform oversight on data management activities (data review and analysis, both clinical& operational, to propose actions and a remediation plan).
  • Ability to appropriately delegate responsibilities for outsourced activities.
  • Good written and verbal communication skills.
  • Good negotiation skills.
  • Strong English skills (i.e., ability to exchange fluently including negotiation, lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication).
  • Alert on purpose, communicate on issues with proposed action plans.
  • Ability to adapt his/ her communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first.
  • Encourage collaboration and communication within and beyond the team.
  • Make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive).
  • Experience with vendor management for outsourced activities.
  • Ability to effectively interact with scientists and managers within and outside Clinical Sciences Organization (CSO), serving as an internal consultant on the assigned area (e.g. Subject Matter Expert) and liaise with external organizations on projects.
  • Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers).
  • Demonstrated ability to adapt and be flexible to change, managing internal and external challenges & opportunities.
  • Knowledge of industry data management standards and practices.
  • Understanding of database concepts.
  • Knowledge of international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems, processes, and SOPs).
  • Strong working knowledge of Microsoft Office.

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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