Sanofi Group Senior Clinical Trial Manager in Bridgewater, New Jersey
The Senior Early Development Operation (EDO) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of early development clinical trials. The EDO Sr. CTM is the leader of the clinical study team and empowered to drive the management & delivery of the study team operational objectives , ensuring all trial deliverables are met according to the study timelines, within budget and having the highest quality standards (GCP / ICH, SOPs / QDs).
The EDO Sr. CTM leads the preparation of study related plans and materials, identification of study risks and contingency planning, appropriate escalation of issues, monitors the study planning, manages budget to ensure it is kept within budget and leads the execution of the study with integrity and suitable for regulatory review.
The EDO Sr. CTM leads cross-functional study teams: responsible for the coordination of internal/ external stakeholders, organization of internal team meetings, drives and oversees vendors for the flawless execution of studies. Responsible for management of Clinical and Medical Service Providers, set up & oversight of service providers and ensure adherence to scope of work within timelines and budget.
The scope of this position requires excellent communication skills (written and oral), a critical-thinking/problem solving mindset and strong leadership to manage across functions and to drive the operational success of study activities. The EDO Sr. CTM may manage studies at the product level (if applicable) and may also participate in intra or inter-department Working Groups.
Knowledge And Skills:
Strong experience/expertise in medicine and medical terminology (including laboratory procedures/techniques and biological knowledge) and GCP/ICH guidelines.
Proficient understanding of R&D processes including the principals of study design and execution; knowledge of industry standards and practices.
Expert and internal consultant on assigned area and liaise with external organizations on projects.
Excellent interpersonal and communication skills (verbal and written).
Self-motivation, flexibility, attention to detail and organizational skills, goal-oriented.
Expert in building optimal collaboration within the company and with external partners.
Excellent ability to work in a team environment.
Solid project management skills.
Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot).
Cross-functional leadership fostering team spirit and team motivation (teamwork), e.g. study team or transversal project team.
Display stakeholder management skills (e.g. ability to manage expectations).
Experience with various computer systems/database; a willingness to learn new systems/databases.
Excellent ability to prioritize activities.
Results-driven in terms of timelines and quality.
Bachelor's Degree + 10+ yrs. laboratory or medical experience.
6+ years in clinical research, of which 5+ years spent in clinical operations project management.
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.