Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. 

JOB PURPOSE

• To provide a competitive operational expertise in clinical development and biomarker validation of early phase trials from First In Man to Proof of Concept
• To set-up, conduct and deliver clinical studies for early phase clinical trials while optimizing costs, timelines and quality 

KEY ACCOUNTABILITIES

• The EDO Global Study Manager (GSM) is responsible for the overall operational planning, management and execution of Early Development Operations clinical trials in compliance with ICH, GCP’s, SOPs, local requirements, internal/departmental guidelines, and established timelines
• The GSM is the leader of the clinical study team and empowered to drive the management & delivery of the study team operational objectives, ensuring all deliverables are met according to the study timelines, within budget and having the highest quality standards. The GSM is responsible to coordinate EDO operational teams including co-GSM, DM, CTA
• The GSM can be involved in field monitoring activities of their own studies according to workload/need and/or manages local monitoring or outsourced monitoring
• The GSM may also participate in intra or inter-department Working Groups 

The job may include international responsibilities and tranversal activities such as

• Manage CROs, oversight of outsourced clinical trials to ensure study progress according to study timelines
• Manage outsourced centralized activities
• Manage study sites
• Country management and coordination of Clinical Study Units
• Mentor and train/coach GSMs, GSMs apprentices or trainees
• Lead or participate in department or inter-department Working Groups

PROFILE

Work Experience

• 5 years minimum in clinical research preferably in clinical trial management, including international background

• Strong expertise in clinical early and late development

• Monitoring experience or related experience is required

• Clinical Trial Management or Project Management experience is preferred

• Ability to promptly and efficiently deal with complex and cross-functional “business situation” (risks and opportunities) in a manner that is very likely leading to a positive outcome 

Minimum required skills

• Strong experience and expertise in medicine, medical terminology (including laboratory procedures/techniques and biological knowledge) and GCP/ICH guidelines

• Very good understanding of R&D processes including the principals of study design and execution; knowledge of industry standards and practices

• Self-motivation, flexibility, organizational skills, autonomus, goal oriented

• Strong leadership and Project Management skills

• Ability to work in a team environment

• Ability to prioritize activities

• Capability of interacting effectively with scientists and managers from various disciplines on an international environment

• Ability to liaise with experts or external partners

• Interpersonal and communication skills (verbal and written)

• Experience with various computer systems/database; a willingness to learn new systems/databases 

Minimum preferred skills

• Phase I experience preferred

• Knowledge of data management activities

• Experience with management of outsourced activities 

Education

• Bachelor’s degree 

Language Requirements

• Strong English communication skills (verbal and written) if English is a second language

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.