Experience

GENFIT

• France
• Biotechnology
• 100 - 200 Employee

• Clinical Operations Director

  • Jan 2021 - Present

  At a glance• Therapeutic area knowledge in NASH & PBC diseases • Broad experience in clinical studies from Phase I to IV• Coordinate all operational aspects of global clinical studies • Provide close reporting on study progress and performance to VP Clinical development and CMO• Proven ability to successfully deliver complex clinical development programs• Ability to operate on a strategic level and communicate effectively with other senior leadership

• Clinical Development Manager

  • Oct 2017 - Dec 2020

  Responsible for the operational management and oversight of assigned clinical trials. Works closely with the VP Clinical Development, VP Clinical Operations, CMO and other cross-functional representatives including Biometrics, Regulatory, Safety, Quality and Financial Directors to ensure successfull delivery of projects with quality and within the required timeframe and budget.

• Senior Clinical Development Project Manager

  • Mar 2016 - Sep 2017

  Responsible for the operational management and oversight of clinical trials conduct. Provide oversight of vendors, contractors and consultants.



Transgene

• France
• Biotechnology
• 100 - 200 Employee

• Senior Clinical Trial Manager

  • Jan 2014 - Mar 2016

  Within the clinical development of targeted immunotherapies for the treatment of cancer and infectious diseases : ●Ensure the development and conduct of clinical trials in accordance with regulatory requirements, quality, time and cost, taking into account the safety of patients. ● Responsible for the operational implementation of development plans and the conduct of clinical studies. ● Coordinate the activities of internal and external partners, as required for the implementation of projects, keep their motivation and oversee their adherence to the requirements quality. Show less



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Project Manager

  • Jul 2013 - Dec 2013

  For 2 pediatric clinical studies, international, muticenter, respectively in phase III in infantil rare disease and in phase IV in endocrinology field, conducted in several countries worldwide :●Manage projects from proposal development to final deliverables to the Customer ranging in size and complexity from single service studies to large full scope, multiple protocol projects and/or global projects, with limited interaction from supervisor. This includes management of financial aspects, resources, tasks, risk and quality and requires utilization of discretion and independent judgment as to usage of limited resources. ●Ensure the study is progressing according to internal and Customer quality standards, GCPs and ICH guidelines to fulfill all regulations. ●Facilitate team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training. Show less

• Project Manager

  • Jul 2007 - Jun 2013

  For 3 large international studies of phase III with more than 550 recruited subjects and 1 international study of phase IV with 3000 recruited subjects, respectively in diabetes & endocrinology (Phase III) and oncology(PhaseIV) fields and all run inseveral countries worldwide (EU, NA, Asia and Latin America) : ●Act as a primary liaison between INCR and the Customer to ensure study launch, conduct and closeout according to the Customer’s and INCR’s contractual agreement. Ensures the study is progressing according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations.●Fully manage the executed contract and financial aspects of assigned project. ●Review study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed.●Develop and maintain project plans for the study in accordance with INCR’s operating procedures and work instructions.●Maintain effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensure adequate documentation of each communication.●Maintain and evaluate project progress by managing timelines and other tracking/analysis tools.●Assist in the negotiation and contracting process with outside vendors such as laboratories, printers, drug depots. Show less



MDS Pharma Services

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• CRA / Senior CRA / Regional Project Lead

  • Dec 1995 - Jun 2007

  For several international, multicenter, randomized clinical studies from phase II to IV in various pathologies: ●Trial Coordination activities moving to project management of European trial on large Diabetes study. ●Responsible for monitoring activities in French and Belgian sites. ●Reviewing and approving site visit reports of CRAs. ●Training and coaching of CRAs. ●Escalation of issues to Project Leader. ●Supervisory visits. For several international, multicenter, randomized clinical studies from phase II to IV in various pathologies: ●Trial Coordination activities moving to project management of European trial on large Diabetes study. ●Responsible for monitoring activities in French and Belgian sites. ●Reviewing and approving site visit reports of CRAs. ●Training and coaching of CRAs. ●Escalation of issues to Project Leader. ●Supervisory visits.