Sanofi Group Sr Specialist, Site Management in Bridgewater, New Jersey

The Senior Specialist, Site Management has the primary responsibility to facilitate the exchange of information between the Clinical Project Leader (CPL) and field monitors for a large study or possibly a platform of smaller studies in a particular therapeutic area.

The Senior Specialist will work closely with the CPL to ensure that all aspects of the study that relate to monitoring and site management are conducted efficiently and successfully, thereby enhancing overall project quality and ensuring that clinical timelines are achieved.

The Senior Specialist will 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 Specialist is responsible to support on time delivery of milestones and deliverables.

The Senior Specialist will be responsible for the development of CRA tools, conducting protocol and procedure training in support of the CPL, and support the dissemination of important study information to the CRAs. They may also engage in activities geared toward increasing site performance and direct discussions with investigators to facilitate relationship building and securing optimal site and patient experience.

Responsibilities:

Will work closely with CRAs assigned to Senior Specialist’s trials to assure CRAs are prepared to represent Sanofi at the site level to deliver on milestones and optimize quality.

Liaison between CRA(s) and CPL(s) and support CPL and CRAs in following activities:

  • First contact for CRAs for monitoring questions

  • Contact to follow up with CRAs who miss team meetings to review materials covered

  • Contact to bring common study-related questions or concerns back to CPLs for potential clarification or changes

  • Contact with study team and systems experts to ensure access to systems (i.e., RAVE

  • CTMS, IVRS, ClubNet, etc.)

  • Creator & owner of FAQ document for CRA related questions and posting to share drive

  • Creator & owner of Master Project Reference and study related newsletters for CRAs

  • Contact to proactively anticipate and identify study monitoring risks and strategize with CPL to ensure early intervention

  • Assist in creation of recruitment and retention processes (e.g. development of recruitment strategies, aids, materials, etc

  • Assist with preparation and presentation of slides/topics at Investigator meeting as requested by Global

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

  • Support Project Management and functionally support CRAs on assigned projects to ensure business priorities are achieved through dissemination of critical project information to CRAs and fielding questions

  • 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) to ensure support of project and monitoring activities

  • Participant in teleconferences with Data Management group to reduce DRFs, assist with defining edit checks, etc

  • CTMS study site level set up

  • Study close-out and archiving preparation activities

Training new CRAs on the monitoring aspects of the protocol for all types of visits including Site Selection Visit (SSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) and Close Out Visit (COV) to CRA staff. Assist in the coaching of team members with study initiation visit presentations, prepping for effective IMVs and COV preparation. Also, ongoing booster training as needed to support the needs of the project.

Collaborate with the CPL on site initiation materials, Mock SIVs and offer suggestions/identify gaps/provide solutions for guidelines and materials needed for CRAs to optimally conduct the SIVs.

Work collaboratively and provide input in development of following documents:

  • Annotated MVRs

  • Risk Based Monitoring (RBM) & Source Data Validation (SDV) Plans

  • Monitor Plan

  • Monitoring tools to support the CRAs in their conduct of the PSVs, SIVs, IMVs and COVs

  • Draft CRF

Required Education/Experience

  • Bachelor’s degree

  • 3 years of experience in the pharmaceutical industry or clinical-related discipline (e.g. investigative site) including at least 3 years of direct site management experience as a field CRA

  • Familiarity with medical terminology, general understanding of R&D process and previous exposure to GCPs/ICH

  • Capable of interacting effectively, with minimal support, with Investigators, Trial Operation stakeholders (CTOM/CSD), CRAS 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.

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

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

  • Excellent interpersonal and communication skills (verbal and written)

  • Strong presentation skills (Powerpoint)

  • 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 and co-lead study meetings (SC meetings, CRA Teleconferences, etc.)

  • Ability to adapt and be flexible to change and manage internal and external obstacles

  • Self-motivated, detail-oriented, solution-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 site management skills

  • Familiarity with Windows-based computer applications (eg, MS EXCEL, ACCESS and Powerpoint), eCRFs (Oracle Clinical, Rave, Inform)and working in clinical trial management systems (eg, IMPACT & Clubnet)

Preferred Education/Experience

  • Degree in Scientific discipline

  • Certified CRA credentials

Sanofi US Services, 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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