Cindy JACHYM
Project Manager - Lyon Region
Pharmaceutical industry
Clinical / observational trials
National / international
Project management
36 years old
Driving License
Lyon France
Professional Status
Employed
Unavailable
Junior Project Manager
ICTA PM
February 2013
to October 2018
- Management of national and international clinical and observational trials (Phase I to III) in oncology, ophtalmology, diabetes and gastro-enterology fields
- Internal team and on-field CRAs coordination and training
- Follow-up of monitoring activities (reports, protocol deviations, AE/SAE, issues/actions) and of patient recruitment
- Logistical management of the study (IMP, site and patient documents, materials...)
- Study documents writing/review with the sponsor (protocol, informed consent form, electronic and paper CRF, investigator files, specific study SOPs and according to local reglementation)
- TMF management and audits preparation (CRO and sites)
- Study budget management
- Management of financial agreements and payments (fees and extracosts, Transparency declaration)
- Management of communication with sponsor (TC/regular face to face meeting) and sites (Flashnews, Newsletters)
- Preparation of "Data Review Meeting", "Steering Committee Meeting" (Phase I in USA), medico-scientific review of patient data, queries management
- Management of regulatory submissions/notifications
- Management of service providers (central laboratories, CROs, printers)
- On-field activities : prestudy, initiation, monitoring, close-out and field-based CRAs quality control visits
Research Associate - Biological Formulations Development
UCB Pharma
February 2012
to August 2012
- Stability study on a drug in Phase II clinical trial : "Proteic drug adsorption onto primary packagings. Example of a monoclonal antibody."
- Management of research strategy
- Laboratory analyses (HPLC, GLC)
Operations Associate - Clinical Trial Support Operations
UCB Pharma
March 2011
to July 2011
Internship
Braine L'alleud
Belgium
- Treatments randomization and labelling
- Packaging and treatments shipment logistics to investigator sites according to preservation constraints
Site Study Coordinator
CHU Brabois
October 2010
to February 2011
Internship
Nancy
France
- Clinical trials coordination in adults heamatolgy department
- Management of included patients : protocol visits scheduling, biological samplings collection and shipment to central laboratories as well as complementary exams
- Communication and follow-up with sponsor team : involvement in initiation, monitoring and close-out visits, patient data entry into paper and electronic CRFs
Research Initiation Training - Galenic Pharmacy Laboratory
Faculty of Pharmacy
June 2009
to August 2009
Internship
Nancy
France
- "Formulation of an innovative pharmaceutical form : the composite microparticules"
- Management of research strategy
- Laboratory analyses
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French - Native speaker
Expert
-
English
Advanced
-
Microsoft : Excel, Word, PowerPoint, Outlook
Advanced
-
Internal computer tools for project management
Advanced
-
Rigorous and methodical
Expert
-
Mastery of procedures and regulatory frame
Advanced
-
Ease with internal/external communcation
Expert
-
Transversal actions
Advanced
-
Collaborators accompaniment and skill improvement
Advanced
-
Management of project planning
Good
-
Management of project costs
Advanced
-
Management of project quality
Good
-
Management of project benefits/risks ratio
Advanced
Industry option - University thesis passed in September 2013 - With distinction : "Proteic drugs adsorption onto primary packagings. Example of a monoclonal antibody."
Project management of an innovative biotechnology process
Bacteriology, virology and parasitology
Option Life and Earth Sciences - With honours
