JOB PURPOSE :
ORGANIZATIONAL CONTEXT :
See Organizational chart attached)
SUPERVISED RESOURCES :
KEY ACCOUNTABILITIES :
A. LIAISE BETWEEN SANOFI AND NETWORK SITES
share clinical operations related issues, such as sanofi compliance requirements, sanofi digital innovation for clinical trials, new network sites introduction and so on.
Explore non-CFDA-accredited sites with high recruitment potential and support them to acquire CFDA certificates to become accredited sites in order to have more candidate sites for sanofi studies.
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 :
Education Background :
Experience & knowledge :
Core competencies :
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.