Senior Clinical Trial Manager

Company: Sanofi
Location: Bridgewater
Posted on: June 26, 2022

Job Description:

Our Team:EDO Mission:To provide a competitive operational expertise in clinical development from biomarker validation and first in Man to Proof of Concept trials.To set-up, conduct and deliver clinical studies/databases for early phase clinical trials while optimizing costs, timelines and quality.Job Description:The Senior Early Development Operations (EDO) Global Study Manager (GSM) is responsible for the overall operational planning, management and execution of a of Early Development Operations clinical trials (phase I studies and/or complex patients' studies) in compliance with ICH, GCP's, SOPs, local requirements, internal/departmental guidelines, and established timelines. The GSM 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. The senior GSM is responsible to coordinate EDO operational teams including coGSM, DM, CTA.The senior GSM ensures implementation of project/indication strategies at study level for harmonization.The senior GSM may manage studies at the product level (if applicable). The senior GSM may be involved in monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The senior GSM may also participate in intra or inter-department Working Groups. As applicable, the senior GSM is an ad-hoc member of the global Project Team (GPT) and key member of the clinical sub-team and is accountable to provide relevant updates to all members of the GPT.The job includes international responsibilities.Provide management and oversight of clinical trials (which may include complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelinesManage outsourced centralized activities when applicableManage CROs, study sitesCountry management and coordination of Clinical Study Units if applicableManagement of outsourced activitiesMentor and train/coach GSMs, GSMs apprentices or traineesLead/participate in department or participate in inter-department Working Groups, if applicableOther leadership activities:Interaction with CSO-Project Leader (study reporting, escalations, contributing to operational strategy).Serve as internal consultant for specific departmental activities, if applicable.Serve as Project leader for the department or external to the department be the referent for a specific compound and maintain accurate documentation available for the department, participate in Project Team meetings, if applicable.The Senior GSM could act as EDO DPE to support and coordinate phase I activities on late-stage compound including transversal analysis across multiple studies on a given project.Collect, synthesize, report, file and prepare archiving for clinical trial activitiesWork Experience:5 years minimum in management of clinical trials, including a strong international background.Field monitoring experience or related experience is required.Strong English communication skills (verbal and written) if English is a second language.Successful prior management and/or supervisory experience in clinical operations are required.Clinical Trials Management or Project Management experience required (approximately 5-8 years).Recognized expertise in cross functional operations.Ability to promptly and efficiently deal with complex and cross-functional "business situation" (risks and opportunities) in a manner that is very likely leading to a positive outcome.Minimum required skills: Previous and strong experience/expertise in medicine and medical terminology (including laboratory procedures/techniques and biological knowledge) and GCP/ICH guidelines.Very good understanding of R&D processes including the principals of study design and execution; knowledge of industry standards and practices.Outstanding capability of interacting effectively with scientists and managers from various disciplines on an international basis.Expert and internal consultant on assigned area and liaise with external organizations on projectsExcellent 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.Strong leadership abilities.Extensive project Management skills.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.Minimum preferred skills:Previous Phase I/early patients' studies experience preferred.Knowledge of data management activities.Experience with management of outsourced activities.Experience on digital initiatives implemented in clinical trialsTechnical skills:Education: Bachelor's degreeLanguage Requirements: Strong English communication skills (verbal and written) if English is a second language.Physical Requirements: N/AAt Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.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.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. GD-SALI-SAPDNAt 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.PDN-967128bf-eed8-4834-a2d5-d9317d467a6e

Keywords: Sanofi, Trenton , Senior Clinical Trial Manager, Healthcare , Bridgewater, New Jersey