Clinical Project Manager - Aix-en-Provence, France - Oxford Global Resources

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Our client is a small company based in France (Aix-en-Provence) focusing on breakthrough therapies with a new approach of medical devices.

They are looking for a Clinical Project Manager to join their team and to manage the study on their mitral annuloplasty device (cardiology).

• The CPM is responsible for the planification of clinical operational activities and for managing the execution of the study. The CPM provides overall management of the clinical project, directs the execution of the crossfunctional study and coordinates the execution of the study with the support of the operations field resources.
• He or She coordinates the definition of the project scope, plans and budget, as well as any documents or processes specific to the clinical investigation.
• The CPM is also the main contact for the project and ensures the coordination with all stakeholders (clinical sites, CROs, Core Lab, as well as internally).
• He or She monitors the adequate progress of the project from study setup to closeout in accordance with international procedures and standards (such as ISO 14155:2020) and applicable regulations (such as the EU MOR).
• The CPM provides overall management of the clinical project. In addition, he or she may be involved in crossfunctional projects and will support the VP Clinical Affairs in Clinical Affairs to achieve the objectives of the study.
• The CPM reports directly to the VP Clinical Affairs.

• Prepare technical trial documents such as clinical investigation plan, study reports and manuals, CRFs, followup and completion guidelines, consent form,
• Prepare and manage submissions to ethics committees and authorities.
• Manage site selection, qualification, and initiation.
• Manage study timelines, ensuring that studies are completed within approved timeframes and that and that all reporting obligations are met.
• Manage the approved trial budget, study contracts, tracking of documents and study activities.
• Supervise monitoring activities and review completion and progress of the study.
• Manage the progress of testing to ensure compliance and adherence to the project plan, applicable standards and regulations, internal SOPs. Identify, assess problems and implement solution.
• Ensure the availability and suitability of study supplies and test items at clinical sites.
• Manage the activities and contracts of external parties involved in the study such as CRO, Core Laboratory, Monitors, Negotiate agreements with them.
• Create and maintain all test files, including the master test file, and Supervise the site files.
• Manage the administrative activities of the study, maintain study documentation, collect and review regulatory documentation.
• Manage site enrolment.
• Provide support to clinical sites in their study activities and provide regular and timely information. Gain the commitment of the Site
• Interact with internal teams (regulatory, QA, R&D,...)
• Oversee activities with studyrelated committees such as the Steering Committee, Data Monitoring Committee, Clinical Events Review Committee and Investigator meetings
• Be the main point of contact for the study for internal and external parties
• Provide leadership, motivation, direction to study collaborators
• Provide regular feedback and updates to senior management on project progress, challenges and opportunities
• Beyond the scope of the clinical project,theCPM may also be required to:
• Develop clinical project tools such as standard templates for use across the project
• Supporting clinical activities related to the QMS
• Provide coaching to individual team members as required
• Perform other duties as assigned

• 510 years' experience in Clinical Project Management (studies in European countries)
• Experience in Medical Devices is a must
• Experience in Cardiology is a nice to have
• Knowledge of ISO 14155:2020 & 1348
• Knowledge of Medical Device Regulation (2017)
• Fluency in English
• Someone autonomous, who can deal with stress and won't be scared after the 1st issue
• Someone who understands quickly, take initiative
• Strong communication skills (oral and written)
• Ability to prioritise
• Strong Teamplayer

• Open to freelancer and employee profiles
• Part time : 50% or less
• Start : January 2023
• A balanced salary package based on your skills and experience

• Life balance : 1 days/week on site
• Travel: Remote position with travel 1 or 2x/month