Experience

LinKinVax

• France
• Biotechnology Research
• 1 - 100 Employee

• Project Lead Clinical Operations

  • Apr 2023 - Present



Quantum Genomics

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Project Manager

  • Sep 2020 - Mar 2023



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Clinical Team Manager

  • Apr 2013 - Sep 2020

  Accountable for achieving delivery of clinical activities by meeting internal and external (client and regulatory) requirements according to time, quality, scope and budget constraints. Responsible for clinical monitoring plan and clinical study documents development Identification of clinical risks and issues, development of mitigation plans Responsible for site monitoring activities (tracking and resolution of issues, review and approval of reports) Supervise IP accountability, subject enrollment, CRF monitoring, and query resolution; ensures all reporting systems are up to date, ensure proper filing of study documents in eTMF. Take active part in resources management Collaborate with QA in case of internal or external audit, or for sites requiring implementation of CAPA Ensure that work is done in in adherence with scope and budget. Communicate with other Functional Leads, vendors and client Actively participate in client meetings, assisting with presentations as required. Provide performance / project status metrics internally and to the Sponsor. Active participation to investigator meetings, Bid Defense meetings, Kick off meetings and other client meetings. Experience in Phase II and Phase III studies in solids tumors and onco-hematology (AML, NHL, MF) Show less



Keyrus Biopharma

• Clinical Project Manager

  • Jun 2011 - Mar 2013

  Coordination of the study activities within the study team (i.e; Clinops, Data management and Statistics)Develop clinical monitoring plan and clinical study documents including patient’s facing material (e.g. informed consent forms, patient's diaries, newsletters). Submission to the ECs and competent authorities Creation and update of the study tracking toolsMaintenance of the TMF, ensuring proper filing of study document and accuracyManagement of study budget and invoicingManagement of third vendors Show less

• Contractor Clinical Project Manager at TcLand Expression

  • Nov 2010 - Sep 2011

  Coordination of the external CROs activities (submissions, monitoring, logistical aspects, lab kits ....)Creation and update of the study tracking toolsResponsible for the global newslettersReview and validation of the study documents (eCRF, communication plan, monitoring plan, edit check plan...)

• Lead CRA

  • Jan 2010 - Jun 2011

  Responsible for site management activitiesOn-site visits (Selection visits, Site initiation visits, monitoring visits, close-out visits), management of queries and collection of essential documents.Involved in site contracts negotiation, signature and invoicingProvides project status metrics to the SponsorResponsible for site invoicing

• Contractor CRA at Eli Lilly Company

  • Mar 2007 - Dec 2009

  Responsible for site management activitiesOn-site visits (Selection visits, Site initiation visits, monitoring visits, close-out visits), management of queries and collection of essential documents.Involved in site contracts and invoicing



Gecem

• CRA - Clinical Research Associate

  • Oct 2005 - Feb 2007

  Therapeutic areas : Renal Transplantation, Dermatology, Alzheimer and Depressive Disorder Phase II, III and IV Monitoring activities on site : selection, site Initiation, monitoring and close-out visits - Management of the sites : regular contacts to ensure compliance to study procedures, to keep motivation and enrollment - Payment activities (Invoicing) Therapeutic areas : Renal Transplantation, Dermatology, Alzheimer and Depressive Disorder Phase II, III and IV Monitoring activities on site : selection, site Initiation, monitoring and close-out visits - Management of the sites : regular contacts to ensure compliance to study procedures, to keep motivation and enrollment - Payment activities (Invoicing)