Sanofi Group Global Trial Operations Manager, Swiftwater, PA in Swiftwater, Pennsylvania
Senior Global Trial Operations Manager
The Senior Global Trial Operations Manager (GTOM) is a member of the newly organized function within Clinical Programs (CP) team, part of Pasteur R&D.
The Senior GTOM is responsible for all operational aspects of clinical study oversight, including the delivery of every study on time within budget, quality and scope in compliance with GCPs, SOPs and standards.
The Senior GTOM manages and coordinates the planning, the feasibility/evaluation and the execution of clinical studies performed as part of the vaccine clinical development plan.
The Senior GTOM co-leads Clinical Team meetings and works in close collaboration with the Clinical Team members (i.e. representatives from all clinical functions), in addition to other key players from various
departments outside of Clinical that support the study (GCI/NAMP Pasteur central laboratory, Clinical Quality Assurance, Clinical Study Units, Regulatory Affairs, Finance).
The Senior GTOM is also responsible to manage third parties/vendors (not related to monitoring activities).
The Senior GTOM acts with a critical mindset and problem solving mindset, and is in charge of the identification of study risks and contingency planning.
The Senior GTOM also contributes significantly to Pasteur or Sanofi initiatives of Process harmonization/improvement.
Working with Clinical Team members, the Senior GTOM:
Ensures proper study set-up and provides oversight of the study to ensure progress according to study timelines
Ensures proper set-up of Trial Management tools (CTMS, IRT…) and adequate management of study documentation availability; coordinates the Study Risk Management Plan; reviews study documents (protocol …) and study plans (Centralized Monitoring Plan, Monitoring Plan…)
Organizes study specific meetings (Clinical Team meetings, Investigator Meetings, other ad’hoc meetings)
Collects, synthesizes and reports study information to CP upper management
Participates in selection and management of vendors (non-monitoring related activities) and operational experts, develops and performs follow-up of the associated budget
Is accountable for the preparation and follow-up of the study budget (SPE)
Is accountable for the preparation and oversight of study audits/pre-approval inspections (PAI)/inspections
Mentors newcomers and/or apprentices on processes and global tools
Contributes to initiatives and working groups on-the-job and linked to process improvement
● Minimum Bachelor's Degree required
● 4+ years’ experience in vaccinology or clinical research
● Formal training in GCP
● Proven track record in delivering high quality GCP-compliant clinical trials
● Minimum of 1-2 years of experience in Clinical Trials
● Knowledge of FDA requirements and other local regulatory requirements; ability to ensure compliance with local requirements
● Fluent English communication skills, verbal and written
● Experience in the management of vendors for outsourced activities
● Leadership in a multicultural environment
● Make decision when needed and take responsibility
● Project Management and budget management expertise
● Positive mindset and behavior – Strong team spirit
● Demonstrated ability to adapt and be flexible to change, managing internal and external challenges & opportunities
● Excellent interpersonal and presentation skills
● Ability to work independently and acute organization / prioritization mindset
● Ability to anticipate, timely escalate issues and to define appropriate action plans
● Demonstrated team and negotiation skills
● Resourcefulness; ability to find solutions to operational problems
● Strongly results oriented
● Intellectual curiosity, creativity
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.
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, Empowering Life