Experience

Clinear Research

• Mauritius
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director | Clinical Project Lead | Clinical Research Consultant

  • Nov 2015 - Present

  ➢ Mentoring, training, and management of CRAs/CTAs/QM and other Clinical Trial staff (employees and vendors) ➢ Quality check and Maintenance of trial master file. ➢ Ensuring communication and awareness of all monitoring metrics and critical issues. ➢ Coordinating site monitor activities in partnership with corresponding PMs/PCs/other actors. ➢ Tracking visit and trip report metrics, reviewing visit reports and summarizing/reporting to teams ➢ Organization, preparation, and hosting of DSMB meetings and Investigator meetings (on-site and remote presentation). ➢ Developing Clinical Monitoring Tools and Source Document Templates ➢ Verifying and managing IMP and study stocks on site. ➢ Regulatory submission (Mauritius, France, Netherland, Belgium, Germany). ➢ Conduct site selection visits and start-up activity, international and national study management, and monitoring visits in Mauritius and Reunion Islands. Freelance CRA/PM on: - An international Phase I/II in Preeclampsia - an international phase III study in Lupus (Mauritius and Reunion Islands) - an international phase II study in Hepatology (Mauritius Island) - an international phase III study in Dermatology (Mauritius) - an international phase III study in Cystic fibrosis (Reunion) - an international phase III study in AmyloÏd Polyneuropathy (Reunion) - an international phase III study in Obesity (Reunion) - an international phase II study in severe Systemic Lupus Erythematous (Mauritius) - an international phase II study in NASH (Mauritius and Reunion) - an international phase III study in hepatitis (Mauritius) - an international phase III study in Glaucoma (Mauritius and Reunion) - an international investigational device study measuring Ocular Hypertension (Mauritius) - an international phase III study in Rheumatoid Arthritis (Mauritius and Réunion) - an international pilot study in Gynecological Procedures (Réunion) -A european phase-II clinical trial in type 1 diabetes (Western Europe) Show less



pharmatch.co

• France
• Business Consulting and Services
• 1 - 100 Employee

• Clinical Research MatchMaker pharmatch

  • Apr 2021 - Present



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Clinical Research Associate

  • Aug 2011 - Oct 2015

  • Clinical Research Associate, PAREXEL International, Paris, France, from September 2011 Responsibilities :  Clinical trials monitoring in accordance with the ICH Guidelines, the current monitor guidelines and SOPs including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis, preparation of audit and performing site close-out visits  Junior CRA onsite trainings  Participating in kick-off and investigator meetings.  Conducting protocol, study procedures and ICH-GCP trainings to investigational teams  Coordinating vendors and ancillary tasks (payments/reimbursements, Central laboratory, contracts, etc.) with in-house project team.  Performing drug accountability reconciliation and IWRS management.  Detecting protocol/procedure deviations/deficiencies and implementing CAPA processes. THERAPEUTIC AREA EXPERTISE  Oncology : Thyroïd cancer, Renal Cancer, Breast Cancer, Lung Cancer.  Gastro Enterology : Crohn’s disease.  Pulmonology : Bronchiestasis. Show less



i3 Research

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Clinical Research Associate

  • Feb 2010 - Aug 2011

  Site monitoring visits, management of cut off timelines, management of queries and SAE, investigational products management, management of Central Files, mentoring junior CRAs. Site monitoring visits, management of cut off timelines, management of queries and SAE, investigational products management, management of Central Files, mentoring junior CRAs.



Ambroise Paré

• Région de Boulogne-Billancourt, France

• Clinical Project Coordinator

  • 2008 - 2009

   Gathering all projects information: schedules, data requests, assignment task, and project meetings.  Working with projects team to understand and assist with tracking all work, task and project assignments.  Working with members of the department to define problems and clarify study objectives. Training of clinical team members.  Coordinating with other hospital departments to obtain data and ensure data integrity.  Gathering and compiles documentation on standard data sets.  Conducting or coordinating special analytic projects as assigned.  Negotiating Research Site Clinical Study’s budget and preparing contracts by : • Reviewing industry study start-up basic contract content : “indemnification; other agreements including data use, confidentiality. • Developing study budget presentations : Based on objective market data; subject vs. visit based. • Anticipating protocol amendments and procedure changes; financial checks and balances. • Assessing protocol feasibility and resource needs : by Looking for hidden costs; study start-up to final query resolution.  Anticipating any limiting factors for study success and establish a preventive actions plan on a timely manner. Show less



Hôpital Ambroise Paré

• Région de Boulogne-Billancourt, France

• Clinical Research Coordinator

  • 2007 - 2008

  Conducting site initiation and close out visits, attending monitoring visits from CRAs, patient screening, data collection and data entry in paper or eCRFs, AE/SAE reporting, following up and solving data queries, attending CRA meetings, attending site audits, preparation of biological samples, management of study drug, management of Investigator Site Files. Conducting site initiation and close out visits, attending monitoring visits from CRAs, patient screening, data collection and data entry in paper or eCRFs, AE/SAE reporting, following up and solving data queries, attending CRA meetings, attending site audits, preparation of biological samples, management of study drug, management of Investigator Site Files.