Project Manager M/F Research Department

PROJECT MANAGER

-ENGINEER M/F RESEARCH AND INNOVATION DEPARTMENT CDI -FULL TIME TO BE FILLED AS SOON AS POSSIBLE I.

General presentation of the CHU

Composed of approximately 2,700 beds and places, the CHU de Poitiers extends over 5 sites (Poitiers, Châtellerault, Loudun, Lusignan, Montmorillon) distributed across the entire territory of Vienne.

As a reference healthcare establishment with a regional vocation, the CHU de Poitiers ensures both a local mission for the 436,000 inhabitants of Vienne and a regional referral and recourse mission for the 1.8 million inhabitants of Poitou-Charentes.

The CHU de Poitiers is organized into 15 clinical and medico-technical activity poles.

With nearly 8,000 professionals, it is the primary employer in Vienne.

II.

Proposed position

The CHU de Poitiers is looking for a project manager to manage multicentric studies for which it is the sponsor, in various therapeutic areas.

The project manager will be responsible for coordinating the different stages of implementation and project monitoring, supervised by the project monitoring manager.

-General missions -For the various projects, depending on the stage of progress:

-Participate in the drafting of the protocol and research documents in collaboration with the coordinating investigator -Participate in the preparation of the regulatory file in collaboration with the regulatory project manager -Conduct the feasibility study in the investigator centers -Participate in the design of the paper case report form from which the e-CRF will be developed, in collaboration with methodologists and the coordinating investigator -Set up the study's logistical circuits and ensure that each selected center has the adequate means to conduct the research -Monitor the conduct of projects by:

- -The training and supervision of CRAs, -The supervision of the drafting of documents necessary for project management and monitoring follow-up, -The verification of monitoring quality, -The coordination of communication related to research (drafting and / or validation of Newsletters, transmission of current documents, relations with Data Management and Vigilance, etc.), -Monitoring patient recruitment compared to planned recruitment: implement necessary actions in case of insufficient recruitment, -The organization and facilitation of team meetings and drafting of minutes, - -Set up monitoring tools (track inclusions, product orders, equipment supply), -Prepare or supervise any Substantial Modifications to the protocol and associated documents -Ensure project planning: establish a provisional schedule, manage deadlines and due dates.

-Coordinate the activity of the various stakeholders during research projects: CRA(s), Data Management, Regulatory Unit, Clinical Trial Vigilance Unit, Pharmacy, Biomedical Service, Methodologist / Biostatistician, Laboratories, etc., -Manage relations with partners and associated contracts in collaboration with the valorization officer - -Nature of contract and recruitment conditions -- The position is to be filled in CDI as soon as possible

• Your remuneration will be fixed based on your training and experience, on an Hospital Engineer grade, category A (hospital public service pay scale), i.e., a salary starting from 28K gross/year

-Working time quota -Full time III.

Required profile

-Required diploma and training - -Higher scientific education (minimum Bac +5 in biological sciences, pharmacy or other health discipline) completed by training in clinical research (DIU-FARC, DU, Master, other qualifying professional training) -At least 5 years of experience as a CRA, including conducting monitoring of studies involving a drug and/or a medical device, at least 2 years as a multicentric research project coordinator or at least one year as a project manager - -Required skills and qualities -Hard Skills:

-Management aptitude, ability to prioritize.

-Ability to evaluate malfunctions and provide corrective actions -Communicate with participating centers -Conduct and facilitate meetings -Autonomy, sense of responsibility, rigor, availability, ability to report to hierarchy.

Training, Knowledge and Required Qualities:

-Knowledge of the functioning of a public healthcare establishment -Good knowledge of clinical trial methodology and regulations -Mastery of scientific English -Sense of organization, spirit of initiative, dynamism and reactivity.

-Reliability, discretion and confidentiality.

-Pedagogical sense and interpersonal skills (listening, tact, respect, courtesy).

-Mastery of tools...