Clinical Research Associate
1 day ago
Bordeaux
Job description Clinical Research Associate M/F/X The company The European Society for Vascular Surgery (ESVS) is a member-based not-for-profit organisation gathering +3500 vascular surgeons in Europe and beyond. Our mission is to improve vascular health for the public benefit. Activities include education and training, as well as science dissemination and creation. The Project As part of the latter, ESVS launched a couple of years ago its first registry, namely the European Venous Registry for deep venous diseases (EVeR) aiming at reducing the lack of robust data to inform the outcomes of deep venous interventions. The second registry scientifically managed by ESVS is an industry PMCF registry. Medical device regulations prioritise the need for improved long-term data collection on all vascular technologies, which is expensive and difficult to gather. Access to a central repository of data is helpful for industry and all stakeholders. Thanks to registry outcomes, it is expected that patients will benefit from the best deep venous treatment according to scientific evidence. The team ESVS is run from its headquarters in Bordeaux, France. We are looking for a Clinical Research Associate to join the team, currently composed of 11 staff members, and manage the registry. They will report to the Clinical Research Manager. The essence of the ESVS Office is to support pan-European vascular surgeon volunteer leaders. Therefore, the Clinical Research Associate will be in regular communications with high-level surgeons and university professors from all over Europe. Most meetings are online but some onsite meetings in various European destinations should be expected. The Registry project’s governance includes a Principal Investigator (PI) and a Steering Committee that the Clinical Research Associate will also support. The objectives The Clinical Research Associate will be responsible for: • Supporting the Clinical Research Manager in the successful and smooth registry setup and management, • Support in protocol drafting, • Supplier and partner coordination, • Data monitoring, • Data quality, • Respect of GDPR according to the DPO’s recommendations, • Excellent user experience, • Happy stakeholders, • Support in CRO service development List of stakeholders Project stakeholders include: • The Client, • A statistician, • Key Opinion Leaders (KOLs), experts in aortic interventions, • Medical centres / hospitals and their ethics committees, • Partners representing other stakeholders, e.g. patients, regulators, • Data Protection Officer (DPO), • Software supplier Job description • Committee coordination: Steering Committee meetings § Meeting preparation § Meeting attendance & minutes, if required § Follow-up actions • Stakeholder & partnership management § Stakeholder relationship maintenance § Query management § Contract implementation and follow up § Support in recruitment of medical centres • Finance administration and coordination § Invoice preparation, payment tracking § Invoice collection, coordination, payment preparation § Budget updates • Data monitoring management § Support in data monitoring process development § Management of monitoring § Collecting / drafting of monitoring reports • Data and software coordination § Coordination with the software supplier § Coordination with all stakeholders § Dataset update § Data monitoring § Preparation of custom reports § Annual report support § Software coordination • Project support § Support all aspects of the project, i.e. project timeline, milestones, deliverables, budget, reports, stakeholders § Updates of processes § Support in marketing and communications § Support and reporting to the Clinical Research Manager o Support the CRO branch development § Market investigation and reports § Compliance reports § Support in developing the service o Support the office team with any other project § In a small team and an dynamic work environment, ESVS activities might evolve with time, some increasing, some requiring less support, leading the team to adapt and be flexible to support Committees and projects. It is expected that the Clinical Research Associate can also support other ESVS projects if time allows. Specific skills • Fluent in English, • Professional French proficiency, • Excellent communication skills, • Excellent project coordination skills, • Familiarity with software, • Experience with registries, clinical studies, trials or investigations in the medical field, • Experience with regulatory projects and compliance, • Adaptability, quick learning skills, multitasking, • Detail-oriented, • Analytical skills, • Transparency and accountability, • Ability to work autonomously, • Ability to manage work peaks, • Diplomatic skills, professional attitude, • Work experience abroad, • Ability to travel (if requested) Conditions • Working language: English (French with suppliers), • Full time position, • Permanent contract (CDI), • Annual gross salary: 30k€-35k€, • Start date: asap, • Job location: Bordeaux, with some working from home permitted, • Staff incentives ESVS is an inclusive employer that values and actively promotes diversity and inclusion within its team. We embrace individual differences and foster a respectful, supportive, and welcoming work environment. We believe that diverse perspectives strengthen our organisation, enhance collaboration and innovation, and ensure that every team member feels safe, respected, and valued in their role.
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