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Sanofi Group Site Partnership Manager in Bridgewater, New Jersey

Introduction to the Sanofi Site Partnership model:

Site Partnership model, while building a strong relationship between Sanofi and sites, will position Sanofi as a priority sponsor at the site level. Also to help deliver on objectives associated with speed & cost reduction by increasing the number of patients per site, as well as introducing operational efficiencies and optimizing study performance and timelines. This will be achieved by a close collaboration between the site and the Site Partnership Manager (SPM). Site Partnership Management Model includes various tiers of sites:

  • Premier sites, while achieving high standards of performance and quality, are also leveraged at more global strategic level.

  • The Partner sites are contributing to the operational components with increased focus on recruitment and retention. They can also be supporting protocol design as needed.

The Site Partnership model objectives align with overall CSO/CSU objectives for the Roadmap 2020 and support portfolio priorities (i.e % decrease of number of sites to achieve the same # of patients, increase the # of pts per sites, reduce overall non-performing site metrics, accelerate clinical development timelines etc.).

Overall Responsibilities:

The Site Partnership mission is to build strong relationships, enhance level of collaboration, and harness input and insights from Investigational sites to drive site performance such as increasing the no. of patients/site, accelerating study start up and reducing overall development milestones through faster patient recruitment. The Site Partnership model will enable early CSU planning to ensure early site relationships exist ahead of future programs and studies. These objectives will be achieved by:

  • Providing Transversal Partnership: single point of contact across and in between studies to improve protocol design elements, optimize clinical trial operations, improve site anticipation of upcoming studies, establish effective patient recruitment and retention plans.

  • Portfolio Planning: Pro-active review at program and study level with sites to provide sites with ample time to prepare for a new study, including activities that promote early identification of potential study participants and reduce local competition for study subjects. Portfolio planning is also expected to increase the enthusiasm around Sanofi programs and investigational/ post market access products.

  • Establishing two way communication between Site & Sponsor: Influencing Protocol design, recruitment strategies, operational efficiencies, decreasing site and patient burden.

  • Site Performance: actively review metrics and mutually agree on actions, explore new approaches with sites to drive operational excellence in a changing environment. Exemplifies the culture and expertise to ensure effective site performance and engagement

Site Partnership Manager (SPM):

  • The SPM has the primary responsibility to be point of contact for Partner Sites including Premier Sites. Champion communication between study teams and sites to develop a more cohesive partnership, the SPM fosters open and transparent communication between sites & Sanofi (status, risks, performance, etc.)

  • The Partner site model increases the overall direct contribution of clinical trial centers to the operational components with increased focus on recruitment and retention. This will require transversal collaboration with the Global Site Partnership Manager, feasibility, patient network, Medical Advisors, Clinical Research Operations Manager, Study Teams (internal and outsourced) and digital innovation teams.

  • Anticipates and pro-actively maps sites capabilities versus portfolio, identifies risks in link with program/studies execution based on partner sites feedback, etc.

  • The SPM will be the local liaison and SME for clinical trial optimization based on site feedback. As part of this SME role, they will collaborate proactively with all stakeholders and ensure the insights/best practices gained are communicated as well as lessons learned to reduce repeated operational complexities. The SPM must possess strong influencing skills to ensure implementation of site recommendations and best practices at the global and local levels.

  • To ensure that the appropriate centers are actively engaged in all stages of clinical trial development activities from protocol development through to study completion (strategy) in addition to the operational component of the clinical trial thus contributing to accelerated clinical development of Sanofi compounds as shown by site performance and quality.

  • Depending on the status of the site, Premier or Partner Site, SPMs level/Frequency of activities and support might vary.

Knowledge:

  • Highly knowledgeable in Investigator site management, clinical trial operations, study development, FDA Regulations and ICH/GCP guidelines.

  • Good knowledge of the pharmaceutical industry and healthcare systems within the region.

  • Effective team communicator that promotes transversal collaboration

  • Proactive portfolio planning

  • Critical thinking & problem solving

  • Team training

  • Metrics and analysis

Skills

  • Required soft skills: excellent communicator, effective presentation skills, good interpersonal skills, critical thinking, ability to work within a team setting, ability to quickly build relationships and trust, to influence. Mastery of these soft skills has to be demonstrated by the candidate

  • The ability to implement innovations and adapt to change

  • The candidate must be proficient in English

  • The SPM must possess strong influencing skills to ensure implementation of site recommendations and best practices at the global and local levels. The candidate must be able to travel up to 25%

  • Proficiency in general systems and applications such as PowerPoint, Word, Excel and Adobe

  • Account management skills/ mindset as it relates to site and sponsor partnership

  • Ability to formulate patient recruitment and retention strategies; demonstrated reliability in establishing site recruitment predictions and risk mitigation

  • Understanding of study start up complexities, RBM and overall Sponsor- site dynamics

  • Formal Education

Formal Education and Experience Required:

  • Bachelor’s degree + 5 years of experience in the pharmaceutical industry or clinical-related discipline (e.g. investigative site).

  • At least two year experience in clinical trials activities, site facing preferred.

  • 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, certified CRA credentials. Experience in the role of a CRA and/ or previous site management

Principal Duties & Responsibilities:

  1. Collaborate with Global Site Partnership Manager to ensure overall global strategic alignment for Partner sites development in general and get Premier sites engaged at the global strategic level

  2. Responsible for establishing new sites as Partner sites aligned with portfolio and country strategy by working with local stakeholders (eg, MDA, medical directors) in new site recommendations, evaluation and selection to be part of the site partnership management program. Collate information for internal stakeholders, launch, support and train sites new to the partnership

  3. Responsible for Partner sites early and continuous engagement by:

  • Reviewing General Portfolio & Upcoming Studies in light of Premier /Partner sites objectives that achieve operational efficiencies and milestone acceleration

  • Discussing with Site Partners any opportunities related to operational efficiencies, patient recruitment activities, new indications, site development.

  1. Responsible, in collaboration with internal teams, for involving Partner sites and getting robust and meaningful feedbac k during study concept phase (i.e. operational roundtable, pre-assessment) and Operational feasibility

  2. Responsible for patient recruitment and retention (PRR) strategies by:

  • Collect information from Partner sites/Premier in influencing at the early stage of global recruitment strategy as well as local

  • Get support, feedback from Partner sites as needed on recruitment materials, multichannel recruitment strategies, and patient awareness.

  • Collaborate as needed with Patient Network group to facilitate patient feedback through Partner/Premier sites.

  1. Responsible for his/her Partner sites overall performance
  • Discuss, challenge and agree upon patient recruitment target with partner sites and study team, in alignment with Site partnership model expectations.

  • Ensure mutual (site and Sanofi) prioritization at study start up

  • Track overall Premier/Partner site activity and performance using the appropriate tools and propose action plan recommendation accordingly, when risks to recruitment plan identified. If data quality issues identified, SPM will partner closely with the local monitoring team to assure the site delivers quality data per expectations of study timelines.

  1. Facilitate Site partnership model in fully outsourced studies
  • Contribute with other Sanofi stakeholders to ensure that CRO partners are properly leveraging and interacting with the Premier/partner sites

Major Challenges/Problems:

Some sites might require high level of support and prompt resolutions to maintain a strong partnership. Challenge to interact with multiple internal stakeholders and get Partner sites recommendations implemented. SPM will need to demonstrate the ability to influence the global and local teams and get appropriate management support to minimize the overall risk to studies, relationships and portfolio development.

Key Internal & External Relationships:

  • All Clinical Science & Operations departments

  • Strategy and Collaboration

  • Trial Operations

  • Medical Affairs

  • Legal

  • Procurement

  • Finance

  • Patient Network Group and local PAG Champion

  • CRO Project Manager, Clinical study site personnel (for outsourced studies)

Decision Making Authority:

  • The SPM will support the CSU/clinical study team within the CSO/CSU with ultimate goal to optimize Premier and Partner Sites site performance.

  • SPM is leading the evaluation of new sites to be included in the Site partnership model and making strong recommendations to adding sites or removing sites to the program.

  • SPM is a critical member of local CSU cross-functional team (MDA, CROM, CPL) team for key strategic and operational aspects aligned with partner sites. This includes involvement of partner sites in feasibility, approaching partner sites with portfolio of new studies, identifying/implementing operational efficiencies, and taking action with appropriate internal stakeholders related to high level critical issues with the partner sites.

  • SPM will be also accountable to Global Site Partnership Manager (GSPM) for the global Site Partnership Management strategy.

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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