For one of our valued clients, we are currently looking for a "Study Start-up Specialist".
As a Study Start Up Specialist you will participate in site engagement and evaluation activities and make site selection recommendations to the Feasibility Manager. You will coordinate activities associated with start-up at country level for multiple studies. You will be part of a team of professionals working in a Functional Service Provider setting.
- Conduct site engagement calls
- Conduct site evaluation calls or visits
- Collaborate closely with the global study teams, the local clinical team (Feasibility Manager, Oversight Manager, Operation Manager, CRAs, CTAs, Budget Associates, …), the local medical team (Medical Advisors, Science Liaisons, …) and the local regulatory team
- Coordinate, guide and assist with all start-up activities in accordance with applicable local and/or international regulations, standard operating procedures and project requirements
- Perform certain SSU tasks such as ICF review, EC questionnaires completion, respond to EC comments, ISF review, …
- Ensure proper handover to responsible CRA
- Maintain currency and awareness of changes in study start-up processes across government, hospital and industry to resolve any SSU issues
- Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across study start-up
- Ensure all start-up information & requirements are kept up to date in a central repository for the local study team
- Liaise and share best practices with other SSUS's within the organization.
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- Bachelor or Master degree in a life science orientation
- Prior work-experience demonstrating knowledge and understanding of clinical trials (obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
- Experience in oncology is an asset
- Demonstrated knowledge and understanding of ICH-GCP, regulatory, ethics and contractual requirements for starting clinical trials
- Ability to work in a changing and innovative environment
- Ability to work on multiple projects and different therapeutic areas
- Excellent communication skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate and pursue issues to resolution
- Very good oral and written knowledge of Dutch, French and English
- Ability to present clear messages from complex information to all levels in the organization in both written and spoken English
- Experience working as part of a team with a proven ability to make an active contribution to the team's performance and collaboration
- Ability to work very independently within area of responsibilities
- Able to make effective decisions, self-motivated, assertive and display initiative
- Project management and organizational skills and the ability to prioritize and manage multiple priorities with flexibility
- Good working knowledge of common software packages and web-based systems and databases
- Willingness to work home based and office based
- Driver's license B
- A balanced salary package based on your capabilities and experience..
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16450