Clinical Project Manager

Missions

- Providing expertise and contributing to the implementation, monitoring and reporting of actions carried out as part of the IHU FOReSIGHT and the Institut Carnot Voir et Entendre on rare diseases. Facilitating interaction and setting up projects with the CHNO's DRCI.

- Co-ordinate the various stages of implementing and monitoring clinical studies carried out under the responsibilitý of the medical co-ordinator of the CRMR.

⇒ Drafting of the specifications for the activities undertaken by the CRMR and the rare diseases axis of the CIC1423.
⇒ Organisation of meetings of the CRMR operational committeé

⇒ Management of the Feasibility Questionnaireś and allocation of tasks in conjunction with the health executive and the techs coordinator.

⇒ Review of the costs and additional costs proposed in the financial agreements for studies with industrial, academic and institutional promotions; budgetary and financial monitoring so that, among other things, the CIC-CRMR can effectively invoice its services and the procedures carried out.

⇒ Organisation, planning and operational monitoring of activities and resources: management of resources (technical, financial and human); establishment, updating and implementation of procedures and protocols, and organisation/monitoring of continuing training and certification specific to each rare disease study or project.

⇒ Controlling and monitoring the qualitý of services; anticipating, recognising and resolving problems proactively with internal and external teams.

⇒ Supervision of compliance with procedures and regular internal monitoring of rare disease studies
⇒ Ensuring that the budget for studies is properly monitored and that invoicing is followed up in regular interaction with the Qualitý, Finance, Patients and Information System Department of the National Vision Hospital.

- Helping to ensure that the department runs smoothly, under the responsibilitý of the CRMR's coordinating doctor, with the various support services (IT, biomedical, purchasing, technical services); Helping to draw up and use dashboards and activitý reports specific to the field of activitý (required by the supervisory authorities).

- Provide clinical research expertise to the Institut de la Vision's teams working on rare disease areas and in particular to its programmes and partnerships department, which supports researchers and clinicians in their activities to transform their research into innovations for patients and visually impaired people.

- Coordinating the set-up and design of rare disease clinical trials; assisting with funding applications (preparation of dossiers for calls for tender, PHRC, etc.); participating in the preparation and review of documents and regulatory submissions to authorities, committees and administrations in accordance with the CRMR's procedures and applicable standards (protocols and amendments, information for patients and consent forms, ancillary documents).

- Regulatory watch