This opportunity is open for Belgium-based Clinical Project Managers/Clinical Study Lead with experience in IVD.
As Clinical Project Manager, you manage overall clinical operations for assigned global clinical trials/projects as part of product development projects, for CE-IVD as well as US FDA and other global registrations.
You outline the clinical evidence strategy, in collaboration with the multifunctional project teams.
You serve as a core team member of the IVD development team, providing scientific expertise and lead the execution of clinical evidence studies to ensure on-time delivery of clinical development deliverables : timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, regulatory requirements and ICH/GCP guidelines.
As Clinical Project Manager you are a member of the clinical & medical affairs team and report to the Associate Director Clinical & Medical Affairs.
- You design the clinical development strategy in conjunction with the multifunctional project team.
- You prepare clinical study plans that meet product design goals, regulatory requirements, business needs according to Client procedures. You act as point of contact to external stakeholders (i.e. Pharma & other partners) to ensure alignment on all aspects of clinical study design and execution.
- You manage all aspects of contracted clinical service providers (i.e. CRO's, etc.) and act as the point of contact for all contracted clinical service providers.
- You propose and negotiate budgets for clinical studies and external clinical resources.
- You work with the Biostatistician to define the study design and statistical analysis of clinical data. You ensure site compliance with clinical study protocol and ICH/GCP guidelines.
- You lead the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- You participate in assessing performance data generated by investigational sites. You ensure data integrity through completeness and accuracy.
- You comply with all policies, established procedures, and regulations related to clinical research.
- You actively participate as member of cross-functional project teams, ensure cohesion between analytical and clinical activities, and lend support as needed across to cross-functional validation activities.
- You participate in assessing performance data generated by cross-functional teams.
- You acquire understanding of the Client platform principles and "hands-on" knowledge/skills in performing assigned assays.
- You provide clinical support to (clinical) feasibility studies.
- You maintain accurate and timely sponsor/site correspondence and communication.
- You review data, prepare, and present clinical data reviews and summaries.
- You respond to audit and data queries.
- You prepare and present project progress reports to keep management and team informed
- You participate in preparation of the clinical sections of regulatory submissions packages and assist in responding to requests from the regulator regarding the clinical study.
- You have an advanced degree in a scientific field (Master or PhD preferred) or equivalent through experience.
- You have 2-5 years of relevant experience as IVD/Medical Devices Clinical Project Manager (clinical development and validation studies)
- You have previous experience as CRA.
- You have experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) and all aspects of trial and vendor management.
- You have a strong practical knowledge of compliance and regulatory environments (US, EU and rest of world)
- You are fluent in English.
- Existing right to work in Europe required
- A balanced salary package based on your skills and experience, including extra legal benefits.
- Full-time position
- Hybrid working model : minimum 1 day/week on-site (Belgium)
Vacancy number: 22873