ASNIÈRES LES DIJON
Clinical Research Project Manager actively looking for a job
- Planning and implementation of all operational aspects of a trial: regulatory, financial, logistical, administrative and organizational
- Ensuring compliance with study timelines, allocated budget and GCPs
- Ensuring compliance with Regulatory Authorities regulations/guidelines and SOPs.
- Review and writing of project-related documentation (protocol, synopsis, Informed Consent Form, patient diaries, operating guidelines, CRF…)
- Budget elaboration
- Preparation and sending to Health Authorities initial submission of studies and amendment(s) (ANSM, EC, CNIL, CCTIRS)
- Notification of studies on clinicaltrials.gov for publication
- Preparation of training materials and working documents for investigators and CRAs
- Set-up of investigational product: order and manage distribution of clinical trial supplies
- Selection, negotiation and management of external vendors
- Collaboration with other functional areas (imaging, central lab, CRO,…)
- Define and follow-up of Financial Agreements and Fees
- Writing the monitoring plan
- Manage the study budget : assessment, planning and monitoring of resources and costs in compliance with the project strategy
- Establish and follow-up study timelines with specific software
- Support to CRAs on study related questions concerning trial procedures and subject eligibility
- Review and validation of Site Initiation, Monitoring and Close-out visits Reports
- TMF archiving
- Interaction with methodologist, data manager, statistics, pharmacovigilance, biology
Mes compétences :
Chromatographie gazeuse
Chromatographie liquide
Management d'équipe
Veille technologique
Spectrométrie de masse
Identification structurale de métabolites
Purification de composés chimiques
Extraction de composés à partir de matrices biolog
Identification structurale de composés par MS
Négociation contrats avec CRO
Bonnes pratiques cliniques
Gestion de projets
Recherche clinique
