Interested in a fantastic project opportunity as Clinical Project Manager within next generation diabetes and cardiovascular healthcare ? Apply now !
Complete oversight and responsibility of ongoing clinical trials.
- Operational delivery of a clinical trial from start to CSR in the set timelines, within budget and with the highest achievable quality.
- Ensuring day to day oversight and management of start-up, conduct and close-out phase of the clinical projects according to the applicable rules and regulations ( including but not limited to ICH E6 (R2), EU regulation, …)
- Watch over progress of the clinical trials in the context of the set timelines, predefined budget and quality.
- Ensuring development of and / or contribution to and review of all the documents needed in context of clinical research ( clinical study synopsis, protocol, project plan, monitoring plan, ICF, data management plan, clinical study report, …)
- Monitoring and managing the study budget as defined per study contract.
- Generating study status updates internally including management on regular basis during conduct of the clinical trials.
- At least 5 - 10 years of experience in clinical trial operations, preferably in international / global drug development; experience in clinical operations in food trials is considered a plus.
- Good knowledge in ICH - GCP
- Experience in conducting trials in metabolic health or chronic inflammation is a strong plus.
- Strong project management skills ( proactive, planning, organized ) including experience in project managing cross-functional teams in clinical development.
- Good communication skills.
- Good inter-personal skills and experience in managing sites, clinical service providers and vendors.
- Experience in Biotech environment is a plus.
- Skilled in working with Microsoft Office programs ( ie. Word, Excel, PowerPoint, ctc.)
- Maintains high ethical standards, including a commitment to values & policies.
- Is aware of and sensitive to, cultural differences.
- Fluent in English ( writing and speaking )
- Masters or bachelor's degree in pharma, life-sciences or health related studies.
- Experience in ( global ) drug development.
- Existing right to work in Europe required
- A balanced salary package based on your capabilities and experience
- 3 days / week (60%)
- 5 month's project with possibility of extension
- Hybrid work (combination of remote work and on-site work in Belgium)
Vacancy number: 20467