R&D-CSU-Sr. Site Partnership Manager-SH
Who we are?
As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.
Who we are?
As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development t as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.
Why start your career path in Sanofi?
- To position sanofi as a priority sponsor at the site level by building a strong relationship between Sanofi and sites;
- To help deliver on objectives associated with speed & cost reduction by increasing the number of patients per site and also by introducing operational efficiencies and optimizing study performance and timelines;
- To leverage net work sites, comprised of premier sites and center of excellence, achieving high standards of performance (patient recruitment and retention) and quality;
- To be aligned with overall CSO/CSU objectives depending on portfolio needs and agreed strategy (i.e. number decrease to achieve the same number of patient, etc.).
Clinical Study Unit, Great China Cluster
A. LIAISE BETWEEN SANOFI AND NETWORK SITES
Propose short-term and long-term development plan of new network sites and new partnership sites in China. Discuss with sites about general portfolio & upcoming studies to ensure sites engagement on studies where they deliver according to network/partner sites objectives; share clinical operations related issues, such as sanofi compliance requirements, sanofi digital innovation for clinical trials, new network sites introduction and so on.
B. SUPPORT SITE & INVESTIGATOR SELECTION
Participate into specific site selections to ensure qualified and productive sites are selected according to product development strategy. Recommend which sites should be or not be selected according to recent progress of ongoing clinical trials and current site resources (human, facilities, patients, etc.) conditions. Work with CPL to finalize the study site list according to summarizing site selection results when encountering internal and external competitive studies or in an even more complicated environment.
C. CONDUCT CO-MONITORING VISIT
Summarize and analyze overall network/partner site activity and performance using the appropriate tools, propose action and recommend correction plan accordingly, or decide any changes of network sites/partnership site pool. Participate in site initiation visit and conduct co-monitoring visit (as alternative to line manager or clinical project leader) to help junior CRA keep patient recruitment and KOL contact on track in case of performance or quality concerns. Support monitoring team to communicate with site staff to understand and resolve any specific issues in key sites; assist monitoring team to dig out the reasons of recruitment delay at site level or study level. Maintain the routine contacts with key sites for ongoing and upcoming studies in specific therapeutic area (e.g. diabetes).
Provide any guidance or training on the topic of dealing with KOLs/investigational sites for CRA and senior CRA in any period if necessary.
JOB-HOLDER ENTRY REQUIREMENTS:
- Bachelor’s degree or above in Clinical Medicine, Pharmaceutics, Nursing or other related major. Familiarity with medical terminology, general understanding of R&D process and previous exposure to GCPs/ICH is required.
Experience & knowledge:
- At least 5 years of experience in clinical operation and/or site monitoring is mandatory.
- At least 2-year experience in the site relationship mannagement.
- Highly knowledgeable in investigator/site management, clinical trial operations, study development, ICH-GCP, China GCP and local regulations.
- Previous experience of project management is preferred, not mandatory.
- Required soft skills: excellent communicator, effective presentation skills, good interpersonal skills, ability to work within a team setting, ability to quickly build relationships and trust
- Team player willing to cooperate with other functional teams
- Proactive portfolio planning
- Stratigic thinking & problem solving
- Good command of English (written and spoken)
- Proficiency in general systems and applications such as PowerPoint, Word, Excel and Adobe
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.