Clinical Study Unit Medical Advisor

Job description

 
The position will mainly be responsible for:

·  Assess the feasibility of clinical protocols by collecting information and documentation on the study to be performed in the cluster countries and by conducting surveys with opinion leaders or potential investigators according to Clinical Science and Operation (CSO) requirements and timing.
· 
Contributes to guarantee investigational site productivity after the study allocated to cluster countries.

·  Contributes in the decision taken for re-assessment and re-distribution of sites for trials with enrollment issues.
·  Contributes in improvement of medical data quality at site.
·  Takes part in the evaluation of action plan to increase the productivity of R&D projects in CSU Turkey Cluster countries that are the under the responsibility of Turkey.
·  Acts as a first line medical support to the CSU team.
·  Supports monitoring team in terms of the translation quality of study documents.
·  Supports preparing answers medical questions raised from authorities (ethical committee, health authorities, etc) for all projects in CSU Turkey and R&D projects in cluster countries.
·  Answers medical questions from investigational sites.
·  Gives scientific training to study teams.
·  Provides medical information related with conducted study to third parties (CRO, Laboratory and radiology centers, etc.)
·  Gives medical input for patient safety reporting (e.g SAE, DILS, SUSAR) and contributes in the corrective actions of the data.
·  Maintains and expands the investigator network in his/her country and in cluster countries.
·  Contributes to the exchange of relevant information between CSO and medical and marketing teams regarding clinical activity of the CSU.
·  Liaises with medical, regulatory and business unit teams in hand-over of R&D products to marketed compounds.
·  Supports the affiliate network of Key Opinion Leader (KOL) when selecting National Coordinators or members of study committees.

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.