Clinical Trial Manager
Bridgewater, New Jersey
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The Early Development Operations (EDO) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of early development phase clinical trials (FIH to POC) in compliance with ICH, GCP’s, SOPs, local requirements, internal/departmental guidelines, and established timelines. The CTM is involved in the operational planning and scientific conduct of the clinical trial and acts as the leader of operational disciplines (Study Team (ST)) to guarantee release of homogeneous high quality clinical data in close collaboration with the EDO Data Manager (DM) and Study Medical Manager (SMM).
The CTM may manage studies at the product level (if applicable). The CTM can be involved in field monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The CTM may also participate in intra or inter-department Working Groups.
MAJOR DUTIES & 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 timelines.
- Lead the Study Team (ST) including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CSSP/CROs, Data Management, Pharmacovigilance, Translational Medicine and Clinical Pharmacology (TMED), Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units).
- Manage the study according to Good Clinical Practices (GCPs) and local and/or national regulations, with responsibilities on product and project level.
- Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Study Medical Manager (SMM).
- Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures
- Solve or coordinate the resolution of issues during conduct of the trial
- Develop and review specific study-related documents
- Develop, coordinate and track the study budget, including invoice validation
- Contribute to contract process
- Manage investigational product supplies (ordering, packaging, and shipment)
- Participate in and contribute to internal audits, if applicable
- Serve as main contact for clinical sites and other outsourced activities
- Manage local MT (CSUs) when applicable
- Manage outsourced centralized activities when applicable
- Participates in development of the protocol/amendments
- Conduct ST and other study-related meetings
- Develop study timelines in collaboration with ST and develop risk mitigation plan as needed
- May perform studies following some Phase 2-3 processes when applicable (multicenter-multicountry Phase 2a trials)
Collect, report, file and prepare archiving for clinical trial activities.
- Manage CSSP/CRO/study sites
- Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions
- Assess CSSP/CRO performance by completing CSSP/CRO post services assessments
- Conduct yearly CSSP/CRO assessment, if applicable
Manage outsourced/sub-contracted monitoring activities, when applicable.
- Lead study-specific training
- Manage performance of monitors
- Review and approve all visit reports
To manage outsourced clinical trial activities, when applicable.
- Ensure Scope of Work is accurate for a given study
- Lead study-specific training
- Manage performance of CRO
- Ensure deliverables from CRO are met per target
Conduct field monitoring activities, if required
- Set-up and manage site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review
- Attend site visits as primary or co-monitor (e.g. when mentoring Associate CTMs)
- Conduct source data validation and other monitoring activities (according to the study-specific Monitoring Plan, if applicable)
- Use eCRF tool for ongoing data review and query generation
- Regularly review and reconcile the Investigator Study File, Investigational Product accountability and biological sample management
- Report visit progress/findings to SMM and other relevant members of the ST and Site manager
- If applicable, review visit reports
Participate to the mentoring and training/coaching of Associate CTMs, apprentices or trainees
- Utilize department mentoring program
- Track mentoring/training progress by meeting with mentee on regular basis
Participate in intra or inter-department Working Groups, if applicable
- Propose and implement process improvements
- Participate in development/improvement of guidance documents
Other leadership activities:
- May serve as internal consultant for specific departmental activities, if applicable
- May 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
- Interact with Partners/Units with or without collaboration of CSO Project Leader in the scope of the clinical trial as well as the clinical development program.
- May collaborate with late phase Clinical Trial Operations Manager in project transition activities for programs moving from early to late phase
- Previous experience with medical terminology (basic knowledge in medicine is preferred, including laboratory procedures/techniques and biological knowledge) and GCP/ICH Guidelines
- General understanding of R&D processes including the principals of study design and execution
- Capability of interacting effectively with scientists and managers from various disciplines on an international basis
- Ability to serve as internal consultant on assigned area and liaise with external organizations on projects
- Good interpersonal and communication skills (verbal and written)
- Self-motivation, flexibility, attention to detail and organizational skills, goal-oriented
- Ability to build optimal collaboration within the company and with external partners
- Ability to work in a team environment
- Project Management skills
- Experience with various computer systems/database; a willingness to learn new systems/databases
- Ability to prioritize activities
- Results-driven in terms of timelines and quality
Formal Education And Experience Required:
- Bachelor's Degree
- 8+ years laboratory/medical experience or 5+ years in clinical research
- 3 years + Clinical Trials Management or Project Management experience
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.
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