Sanofi Group Clinical Project Leader for CRAs (Oversight Clinical Project Leader) in Bridgewater, New Jersey

Job Summary:

The Oversight Clinical Project Leader (OCPL) is responsible for the functional oversight of field-based CRAs in a given region. The OCPL 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 Americas Clinical Study Unit. The OCPL is responsible to ensure on time delivery of milestones and ensure achievement of company and partnership metrics as they pertain to CRA activities.

The Oversight CPL is trained as a CPL and maintains CPL certification for all Sanofi SOPs.

Knowledge and Skills :

Capable of interacting effectively, with minimal support, with Investigators, Trial Operation stakeholders (CTOM/CSD), RCRAS and other associates within and outside CSU; may be required to assist the CPL in providing internal operational expertise on assigned area and liaise with external organizations specific to the clinical trial; may be required to provide local vendor oversight (IRB, Clinical supplies, etc.), or to assist CPL in this function.

  • Working knowledge of clinical study development, FDA Regulations and ICH/GCP guidelines.

  • Operational planning experience.

  • Demonstrated strong leadership potential (trial management experience, Lead CRA experience, etc.)

  • Excellent interpersonal and communication skills (verbal and written); Strong English skills (verbal and written if English is the second language)

  • Strong presentation skills (Power point)

  • Professional demeanor with ability to interact effectively with investigators and managers from multiple disciplines.

  • Ability to proactively identify and propose solutions to operational activities

  • Decision-making and problem-solving skills

  • Ability to work autonomously and to efficiently & effectively provide status reports to support the CPL

  • Ability to anticipate and timely escalate issues and to define appropriate action plans

  • Ability to work effectively on a team and foster team spirit and team motivation (team work)

  • Ability to work in a multiplatform environment (Study Start Up, IP, Safety & Trial Ops) with internal and/or external partners (CROs etc.)

  • Ability to co-manage [manage] and co-lead [lead] study meetings (Investigator / SC meetings, expert meeting, CRA Teleconferences, etc.)

  • Ability to adapt and be flexible to 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 (e.g., MS EXCEL, ACCESS and PowerPoint)

  • and working in clinical trial management systems (e.g., IMPACT)

Formal Education and Experience Required:

Bachelor’s degree + 6 years of experience in the pharmaceutical industry or clinical-related discipline (e.g. investigative site) including at least 5 years of direct clinical trials experience. Familiarity with medical terminology, general understanding of R&D process and previous exposure to GCPs/ICH is required.

Knowledge and Skills Desirable But Not Essential :

Degree in scientific discipline preferred, 2+ years of clinical research field monitoring; and/or +5 years of Study Coordinator site management experience.

Major Duties and Responsibilities:

  1. Assist in providing overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s).

  2. Support Project Management and functionally oversee CRAs across all therapeutic areas to ensure business priorities are achieved.

  3. Allocates workload to ensure optimal productivity, alignment with the priority projects and optimal usage of RCRA staff. Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements.

  4. Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements. Liaises with Clinical Project Leaders (CPL) and Medical Advisors (MAs) to ensure support of project and monitoring activities.

  5. Develops and implements monitoring standards that are consistent across projects and geographic areas.

  6. Reviews samples of site visit reports with regard to company SOPs and worldwide guidelines for monitoring visit reports. Ensures appropriate training or corrective action as warranted.

  7. As part of the overall CPL group - conduct Quality control visits (QCVs) at the request of the project CPL. Communicates findings to project CPL and other team members and management as appropriate and per SOP instructions.

  8. Participate or Lead in program or project specific initiatives and process improvement groups to include acting as a Subject Matter Expert on various topics.

  9. Regular review of study metric reports (Monitoring visits, Monitoring Report Reviews & associated timelines, site specific issues and escalations tracking, site IMPACT compliance) to ensure on time and high quality delivery of studies.

  10. Work in conjunction with appropriate vendor Clinical Research Manager (CRM) to share CRA performance concerns.

  11. Act at Point of Contact (POC) OCPL for assigned trials providing general support to the CPL for overall CRA resourcing strategies and tracking for trial, communicating timelines to OCPL group as a whole and identification and mitigation of risk pertaining to CRA activities at the study level, in consultation with the study specific CPL.

Major Challenges and Problems:

Fulfillment of project timelines and delivery of studies with high quality and as per country commitments. Attrition of CRAs is significant challenge.

Key Internal and External Relationships:

Internal: Project team members (daily), CPLs, RTM, Regional CRAs, MA, CQ&C, & Safety, CROM

External: Clinical study site personnel, Vendor Clinical Research Manager (CRM)

Decision Making Authority:

Key decisions are made daily on assigning workload to RCRAs, as well as which RCRA is assigned to which site. Decisions are made daily concerning RCRA accountability and delivery of CSU commitments. Decisions are made daily identifying risk and developing mitigation plans in regards to activities tied to CRA deliverables.

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.

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