Clinical Research Project Manager
Resume:
RÉMI NITZSCHÉ
Rivière-Rouge, QC, Canada
*********@****.***
https://www.linkedin.com/in/r%C3%A9mi-nitzsch%C3%A9-9a654255/ CLINICAL TRIALS AND OPERATIONS MANAGER
Clinical trials leader leveraging extensive experience overseeing entire project lifecycle in Europe and North America. Strategic thinker and accomplished scientist with expertise in Clinical Affairs and demonstrated ability to plan and execute clinical strategies and methodologies, from early phases to phase IV. Areas of Expertise
Regulatory and Ethics Submissions Central and Risk-Based Monitoring Relationship Management Strategic Planning Data Management CRA and Vendors Oversight Project Supervision Study Start-Up and Closure Contract Negotiation Project Budgeting Sites Activation and Closure. Main Therapeutic Areas
Cardiac Implants Cardiology Heart Failure Hematology Ophthalmology Gastro-Enterology PROFESSIONAL EXPERIENCE
Alimentiv, London, ON June 2021 – April 2023
Sr. Clinical Study Manager
Oversaw international Investigator Initiated Studies and global phase II-IV Pharma industry sponsored studies (Crohn’s disease and Ulcerative Colitis).
Allphase Clinical Research, Ottawa, ON November 2018 – June 2021 Clinical Study Manager & CRA
In charge of phase IV studies in Canada for sponsors and fields of activity (ophthalmology, rheumatology, psychiatry).
CRA in Québec and in Ontario (ophthalmology, rheumatology, oncology). CHUM, Cardiology department, Montréal, QC January 2018 – October 2018 Study Coordinator
Local management of academic and sponsored Heart Failure studies. CR-CHUM, ICU department, Montréal, QC March 2017 – November 2017 National Study Coordinator
Managed the start-up phase of NIH-funded trial Myocardial Ischemia and Transfusion (MINT, NCT02981407) in 30 university sites in Canada.
JSS Medical Research, St-Laurent, QC March 2016 – February 2017 Clinical Project Manager
In charge of phase II-IV studies in Canada and in the USA for various sponsors (cardiology, support to IDE studies in Vagal Nervous System and orthopedy…). Sorin Group Canada, CRM, Markham, ON January 2006 – October 2015 Clinical Operations Manager
• Initiated Cardiac Rhythm Management (CRM) clinical research in Canada.
• Planned and executed clinical strategy with senior management. Participated in the selection of study sites, investigators & Key Opinion Leaders (KOLs). This helped to develop the presence of the company in main hospitals in Canada.
Project Manager of CAN-SAVE R (NCT01219621) and SonR-Echo (NCT01869062) randomized trials (followed up respectively 450 pacemaker participants for up to 6 years in 10 sites in Canada and 350 CRT-D participants enrolled in Canada and Europe). Managed the Echo core-lab (Dr F. Tournoux, CHUM).
• Wrote Clinical Investigational Plans, CRFs and Patient Informed Consent forms.
• Drafted and validated Clinical Trial Agreements and budgets with the finance department. Budget tracking along study lifetime. Oversaw publication process. CRA
Monitored selected sites in Québec (IUCPQ, Québec; CHUM and ICM, Montréal…). Technical field support
Implantable Cardioverter-Defibrillator (ICD) implants, in-servicing in pacemaker’s clinics, as well as technical presentations to KOLs and hospital staff. Support and training on 24-hour Holter systems. Sorin Group, CRM Business Unit, Le Plessis-Robinson, France Scientific Communication Manager, Clinical R&D Department Oversaw scientific communication strategy and implementation for the company, managed contacts with KOLs. Organized symposia, prepared presentations, and posters for conventions. Supervised manuscript drafting and publication.
ELA Medical - Biomedical subsidiary of Sanofi-Synthélabo, Le Plessis-Robinson, France Clinical Development Manager, Medical Direction
Oversaw entire post-Market projects strategy and lifecycle in Europe and in Japan, from conception and launch to publication, managing a team of six.
ELA Medical - Biomedical subsidiary of Sanofi-Synthélabo, Le Plessis-Robinson, France Technical Training Manager, Marketing Department
Trained European physicians, ELA product managers and sales representatives. Certification of Field Clinical Engineers in charge of ICD implantation and follow-up. ELA Recherche, Biomedical subsidiary of Synthélabo, Montrouge and Le Plessis- Robinson, France Clinical Research Engineer, Clinical Research Department. Managed European clinical studies assessing the first dual-chamber ICD (Defender™), including CE-marking trial.
Designed, launched and followed-up on pacemaker and ICD clinical studies in Europe. EDUCATION
Engineering degree (equivalent to BSc.) in Biomedical Sciences University of Technology of Compiègne, France
SYSTEMS
CTMS: iMedidata eTMF: iMedidata Veeva Vault
eDC: iMedidata RAVE, iDataFax, Merative (IBM Clinical) Finances: Acumatica, Concur
LANGUAGE SKILLS
French (native), English (fluent), Spanish (academic)
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