Sanofi Group Clinical Quality, Process and Training Ambassador (CQTPA) in Bridgewater, New Jersey

Job Summary:

The NA Clinical Quality, Process and Training Ambassador (CQTPA) is based in the North America Clinical Study Unit (NA CSU) and is responsible for the quality and training program implementation for all NA CSU clinical, monitoring and support staff. The CQPTA is responsible to coordinate with quality groups and procedures groups and other subject matter experts to develop quality processes and training programs to encompass policies, procedures, guidelines and other relevant materials essential to clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, corporate, global and local SOPs. The CQTPA works cooperatively with the Associate Director, NA CSU Ops, CPL (Clinical Project Leader), as directed, in the quality adherence and training of new and current NA CSU staff and in completing special projects and assignments to further advance the monitoring program. The CQPTA is responsible for training materials for all new and revised Sanofi procedures.

Knowledge and Skills:

Training/presentation experience

Work experience in clinical medicine (e.g. nursing, laboratory, radiology, pharmacy) or pre- clinical area (e.g. pharmacology, toxicology), clinical development

In-depth and thorough knowledge of FDA regulations and ICH/GCP guidelines

Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and presentation software tools (e.g., PowerPoint)

Demonstrated coaching and mentoring skills

Ability to work effectively with research personnel, maintaining a professional demeanor

Self-motivated; Detail oriented; Team player; Flexible

Ability to prioritize workload to meet project timelines, while managing multiple training needs across multiple therapeutic areas

Excellent organizational and time management skills

Experience working in digitization of clinical operations (i.e. virtual clinical trials, EHR, real-world protocol optimization, patient recruitment, engagement & retention, wearables, ePROs, data & analytics

Experience in oncology, hematology, rare diseases

Thorough knowledge of clinical systems and ongoing technical industry trends as they relate to the clinical development process

Project management methodologies

Basic Qualifications:

Bachelor’s degree and 8-10 years of experience in the pharmaceutical industry including a minimum of 2 years of experience in training development/delivery and/or quality support in the conduct of clinical trials. Experience in support of oncology, hematology and rare disease trials.

Preferred Qualifications:

Advanced degree preferred. Knowledge of eLearning, self-paced learning, adult learning approaches for use with a large in- house and remote teams.

Major Duties and Responsibilities:

Coordinate NA CSU training program and conduct systematic, consistent SOP and good work practices training for new NA CSU personnel. Conduct formal training for Monitoring Visit Report Guidelines and, as needed, other essential processes related to NA CSU staff roles and responsibilities.

Implement improvements and track progress to enhance the NA CSU training program. Provide input for additional clinical monitoring related training.

Coordinate and enhance, as needed, the personnel training records tracking program to ensure documentation of training, per the NA CSU SOP. Participate as team member for implementation of new e-learning and tracking tools. Conduct refresher/retraining courses for current NA CSU clinical personnel in accordance with the local NA CSU SOPs.

Act as NA CSU CQPTA , responsible for learning and communicating new corporate processes and procedures.

Participate in Committees/Task Force Teams/Workgroups on an as needed basis, as requested by Management Team, to provide procedural insights and represent NA CSU interests.

Quality Documents: Coordinate and work with local QD authors to make sure QD meet NA CSU and/or US CSU expectations for format and content. Create and launch information letters to group for QD updates. Based on WW QD activity, track needs for local QDs and QD due dates/updates. Manage the local training matrix to ensure compliance with training expectations as required by CSO/Local Quality Documents.

Broaden awareness and understanding of processes, tools, additional regulations governing clinical research, so as to be a resource for the NA CSU staff.

Assist in the coordination and conduct of NA CSU workshops and meetings, as required. Leading and supporting special projects in the digitization of clinical operations (i.e. virtual clinical trials, EHR, real-world protocol optimization, patient recruitment, engagement & retention, wearables, ePROs, data & analytics.

Scheduling and coordinating subject matter experts and other training partners for all NA CSU required trainings, system support, pre-approval inspections, SOPs adherence and quality.

This position requires a great deal of collaboration and diplomacy skills. Integration of new procedures and learning tools will require flexibility; training for new things will require additional focus “change management” to gain more proactive and effective uptake by trainees.

Sanofi US Services, 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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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

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