Sanofi Group Senior Manager, Clinical Project Leader for CRAS-2 in Bridgewater, New Jersey
Senior Manager, Clinical Project Leader for CRAS-2
Sanofi, a global healthcare leader, discovers, develops anddistributes therapeutic solutions focused on patients’ needs. Sanofi has corestrengths in diabetes solutions, human vaccines, innovative drugs, consumerhealthcare, emerging markets, animal health and Genzyme.
At Sanofi US, we are committed to the growth of our people,connected in purpose by career, life and health.
Headquartered in Bridgewater, NJ, Sanofi US is part of aleading global healthcare company dedicated to discovering, developing and distributingtherapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, humanvaccines, innovative drugs, consumer healthcare, emerging markets, animalhealth and Genzyme.
Sanofi US employs approximately 17,000 people across thecountry all dedicated to protecting health, enhancing life and responding tothe hopes and potential healthcare needs of seven billion people around theworld.
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The Senior Manager, Clinical Project Leader (CPL) for CRAs is responsible for the functional oversight of field-based CRAs in a given region. The Senior Manager CPL for CRAs ensures that adequate resources are available to support the clinical trial activities planned and/or ongoing at investigational sites.
They help to support CRAs to ensure compliance to the various regulatory authorities
,ICH/GCP guidelines, and company SOPs. They are responsible for the development of
partnerships with various internal and external customers within his/her region and
working towards continuous improvement for the CRA and their contribution to the North American Clinical Study Unit. The Senior Manager CPL for CRAs is responsible to ensure on time delivery of milestones and ensure achievement of company and partnership metrics. In addition, the Senior Manager is expected to serve as a mentor and identify opportunities for process improvements and efficiency. The Senior Manager will lead the team through change management efforts and lead by example. The Senior Manager will participate in organization wide initiatives representing the CRA perspective for US.
The Senior Manager is trained as a CPL and maintains CPL certificationfor all Sanofi SOPs.
Assist in providing overall adequacy of conduct, data quality, complianceand adherence to timelines for their assigned trial(s).
Support Project Management and functionally oversee CRAs across alltherapeutic areas to ensure business priorities are achieved.
Allocates workload to ensure optimal productivity, alignment with thepriority projects and optimal usage of RCRA staff. Ensures that monitoringactivities within the assigned area are in compliance with GCPs, ICHGuidelines, SOPs and project requirements.
Ensures that monitoring activities within the assigned area are incompliance with GCPs, ICH Guidelines, SOPs and project requirements. Liaiseswith Clinical Project Leaders (CPL) and Medical Advisors (MAs) to ensuresupport of project and monitoring activities.
Develops and implements monitoring standards that are consistent acrossprojects and geographic areas.
Reviews samples of site visit reports with regard to company SOPs andworldwide guidelines for monitoring visit reports. Ensures appropriate trainingor corrective action as warranted.
As part of the overall CPL group -conduct Quality control visits (QCVs) at the request of the project CPL. Communicates findings to project CPL andother team members and management as appropriate and per SOP instructions.
Conduct QCVs when possible for new CRAs or CRAs with any potentialquality or milestone deliver concerns. These QCVs can be arranged in conjunction with CPL to account for theQCV study target or can be over the target amount as necessary.
Regular review of study metric reports (Monitoring visits, MonitoringReport Reviews & associated timelines, site specific issues and escalationstracking, site IMPACT compliance) to ensure on time and high quality deliveryof studies.
Work in conjunction with appropriate vendor Clinical Research Manager(CRM) to address CRA performance concerns.
Ensures Lessons Learned are shared among the OCPL and CPLs, as well aslooks for opportunities for process improvement and efficiency.
Bachelor’s degree 10 years of experience in the pharmaceutical industryor clinical-related discipline (e.g. investigative site) including at least 5years of direct clinical trials experience.
Familiarity with medical terminology, general understanding of R&Dprocess and previous exposure to GCPs/ICH is required.
Capable of interacting effectively, with minimal support, withInvestigators, Trial Operation stakeholders (CTOM/CSD), RCRAS and otherassociates within and outside CSU; may be required to assist the CPL inproviding internal operational expertise on assigned area and liaise withexternal organizations specific to the clinical trial; may be required toprovide local vendor oversight (IRB, Clinical supplies, etc), or to assist CPLin this function.
Operational planning experience.
Demonstrated strong leadership potential (trial management experience,Lead CRA experience, etc.)
Strong presentation skills (Powerpoint)
Professional demeanor with ability to interact effectively withinvestigators and managers from multiple disciplines.
Ability to proactively identify and propose solutions to operationalactivities
Decision-making and problem-solving skills
Ability to work autonomously and to efficiently & effectively providestatus reports to support the CPL
Ability to anticipate and timely escalate issues and to defineappropriate action plans
Ability to work effectively on ateam and foster team spirit and team motivation (team work)
Ability to work in a multiplatformenvironment (Study Start Up, IP, Safety & Trial Ops)with internal and/orexternal partners (CROs etc)
Ability to co-manage [manage] andco-lead [lead] study meetings (Investigator / SC meetings, expert meeting, CRATeleconferences, etc.)
Ability to adapt and be flexibleto change and managing internal and external obstacles
Self-motivated, detail-oriented,ability to handle multiple tasks and to prioritize. Ability to manage
complex or uncommon tasks with appropriate level of supervision/training/coaching
Strong organizational and project management skills
Familiarity with Windows-based computer applications (eg, MS EXCEL,ACCESS and Powerpoint) and working in clinical trial management systems (eg,IMPACT)
- Degree in scientific discipline preferred, 2 years of clinical researchfield monitoring; and/or 5 years of Study Coordinator site managementexperience.
Job: Laboratory/Process/Device Development
Primary Location: United States-US Remote-US Remote
Job Posting: Aug 30, 2016, 1:23:23 PM
Job Type: Regular
Employee Status: Regular