Study Start-up Specialist

Job Description

Responsibilities

• 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.

Requirements

• 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

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