Sanofi Group Clinical Trial Operations Manager in Waltham, Massachusetts
The Clinical Trial Operations Manager (CTOM) is responsible for part of the 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 CTOM supports the Senior Lead CTOM and/or Lead CTOM in the scientific conduct of the study and acts with a critical thinking and problem solving mindset.
This role will be involved in the scientific conduct of the study and act under the guidance of the Senior Lead CTOM and/or Lead CTOM to guarantee release of homogeneous high quality data in close collaboration with others Clinical Science Operations (CSO) department representatives (e.g. Medical Operations). This role will also support the Senior Lead CTOM and/or Lead CTOM for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning ensuring that all activities are managed to the highest quality to strive for safety and effectiveness of Sanofi products.
Provide oversight on study activities to ensure progress according to study timelines.
Support the Senior Lead CTOM and/or Lead CTOM in taking study logistic decisions and implementing operational plan(s) upon endorsement by the study team.
Ensure proper documentation availability.
Ensure proper collection and validation of data and documentation on a timely manner.
Organize and lead study meetings.
Collect, synthesize and report study information.
Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Product (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process.
Participate in 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 area and general responsibilities within their function.
Basic Qualifications Required - Education/Experience:
2+ years of experience in the pharmaceutical industry or clinical-related discipline (including at least 1 year of clinical research experience).
Advanced Degree in scientific discipline preferred, equivalent RN.
3 years of experience in pharmaceutical industry, 2+ years clinical research experience and 1+ years of prior management and/or supervisory experience in coordinating vendors, budget management or country management.
Ability to manage and lead international meetings (e.g. Study Teams).
Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team).
Good Project coordination skills.
Good organizational skills including attention to details.
Ability to develop and maintain an optimized study planning with other functions (including identification of critical path).
Ability to handle multiple tasks, prioritize his/ her activities.
Ability to coordinate multiple interfaces, both internally and externally.
Ability to anticipate, timely escalate issues and to define appropriate action plans.
Ability to work autonomously to efficiently and effectively provide status reports.
Participation to routinely data management activities and oversight, data review and analysis (clinical operational) to propose actions and a remediation plan.
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.
Experience in the management of vendors for outsourced activities is preferred.
Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers).
Ability to learn from experience and develop a change mindset.
May assist trainees/Clinical Project Assistant/Trial Management Assistant and/or new comers in their self-development (project-related activities).
Knowledge of International Standards (e.g. GCP, CDISC, ….), company tools, processes and SOPs.
Good 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.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life