Offres d’emploi

CDG/866/CDG

Présentation de l'entreprise

CDG Conseil, independent executive search and outsourcing (in delegation to our customers) company specialized in Life Sciences, research for one of its clients, Pharmaceutical Laboratory, a:

INTERNATIONAL CLINICAL PROJECT MANAGER (H/F)

Présentation du poste

Within Department of Medical and Regulatory Affairs, provide project management of clinical studies for a large project in the US. The timelines and deliverables for this project are challenging.

·       Close communication and collaboration with US CRO is critical for the conduct of a number of studies with multiple clinical sites across the USA

·       Ensure, from conception to completion, that the studies (including surveys) being conducted in the frame of the project clearly meet the objectives defined in advance

·       Ensure that the studies are carried out in strict compliance with the approved protocol, Laboratory's procedures, GCP and the regulations in force

·       Manage and ensure the interface between the internal or external resources involved in the studies including CRO contract execution and vendor management

·       Interface with internal project team members including regulatory affairs (RA), medical affairs, pharmacovigilance (PV), clinical research, pharmaceutical development, procurement, quality, finance, legal, commercial operations                                           

·       Interface with external resources including CROs, experts, and inspectors of regulatory agencies

·       Fulfill the necessary roles and responsibilities as a member of the extended project team defined in advance by the core project team members, and especially the Clinical Focus Team leader in charge of the Studies which in this case if the Senior Medical Officer the clinical trial coordinator will be directly working with.

·       Set up the studies, including RFP and selection of the CROs (if necessary)

·       Implementation and follow-up of the studies within the allocated budget and deadlines, including financial monitoring

·       Lead  in all the activities necessary for setting up and monitoring the studies

·       Implementation and monitoring of the TMF of the studies, including archiving of study documentation

·       Possibility of occasional trips to the US

There is possibility of evolution of the scope of work according to the internal workload of the department.

Profil

·       Experienced clinical study coordinator (minimum 5 years of relevant experience), US experience preferred

·       Must be operational immediately

·       Accustomed to working in a project team and interacting with internal and external partners

·       Fluent in English (read, written, spoken)

·       Multi-tasking, autonomous, shows initiative

·       Good communication skills (to team members, synthetic reporting to the manager of  essential points & with external service providers)

·       Good knowledge of implementation of budgets and contracts

·       Time zone difference with US-based CRO to be taken into account

Type de contrat

CDI

Lieu de travail

PARIS