Sanofi Group Trial Master File Manager - VIE Contract (W/M) in Bridgewater, New Jersey

#LI-EUR

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.

We are looking for a candidate for a VIE mission of:

Trial Master File Manager - VIE Contract (W/M)

The TMF Manager is the business owner of the Trial Master File (TMF) management (paper or electronic TMF). The TMF Manager is a key member of the Study Team and is responsible for reporting eTMF status.

He/she will be preparing the TMF plan to define TMF strategy depending on the study (e.g. study managed internally Vs study outsourced, QC plan depending on study type…).

He/she will be overseeing TMF completeness, Quality Control (QC) activities performed by the TMF Specialists and following-up on specific actions with the contributors to ensure TMF compliance and completeness at all time. He/she will be responsible for the eTMF lock.

He/she will be providing eTMF training and support to contributors to ensure the TMF plan and best practices are well implemented and followed. He/shewill ensure filing activities are performed by contributors according to quality standards and reinforce inspection readiness.

When there are internal audits or inspections by Health Authorities, the TMF Manager will be the Sanofi representative facing the auditors to provide training to use the eTMF and information on TMF management processes. He/she will be responsible for answering auditors’ questions.

Main responsibilities:

  • Creating/customizing the study CIL (Clinical Immunology Laboratory) for each study in the eTMF tool

  • Organizing the TMF kick-off meeting and setting-up the TMF Plan

  • Ensuring that filing and pre-archiving of clinical trial documents are completed according to internal standards and timelines

  • Ensuring that clinical trials documents are available for internal audits and inspections (sponsor and sites). He/she will be the PAI (Pre-Approval Inspection) contact for TMF aspects

  • Mentoring junior members of the department and participates in specific projects related to the area of records management (i.e. IT project, quality project to align with new regulations, inspection readiness….)

Requirements:

  • High school diploma or equivalent and a minimum of 4 years experience in pharmaceutical industry or clinical-related discipline, good understanding of the R&D processes and previous exposure to GCPs/ICH (InternationalConferenceonHarmonisation-GoodClinicalPractice) is required

  • Demonstrated ability to work in full autonomy and take initiatives

  • Efficient collaboration with internal and external partners

  • Organizational, interpersonal and communication skills (verbal and written);

  • Results driven in terms of timelines and quality; Customer & quality focused

  • Flexibility, diplomacy, efficient in matrix organization and transverse management

  • Is a change management agent

  • Self-motivation, attention to details while overseeing and connecting with cooperating departments; Understands the clinical development process and GCP's

  • Familiarity with application/systems related to record management (eTMF tool)

  • Learning quickly when facing new problems

  • Effective written and oral communication in English, and excellent interpersonal skills

  • Clinical Research experience in clinical operations is desirable

  • Knowledge of ICH Guideline pertaining to the essential documents for the conduct of a clinical trial

  • Curiosity, willingness to be proactive and problem solving mindset

  • Knowledge of Sanofi SOPs (Standing Operation Procedures)

  • Experience with the management of outsourced activities

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