Study Start Up Specialist, French

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Assist Project Management, Regulatory, and Contract and Legal teams with all site-related start-up activities.

• Build relationships with study personnel at sites and serve as the primary contact for Alimentiv during the site start-up phase.

• Prepare, distribute, and follow up on start-up documentation with sites.

• Organize and monitor site start-up activities and data utilizing designated systems and tools.

• Generate reports on insights and metrics pertaining to study start-up activities.

• Collaborate with Project Management to develop a study-specific start-up document package.

• Distribute documents and follow up with sites to secure the necessary executed paperwork.

• Evaluate the content and accuracy of returned documents from the sites, ensuring compliance with internal standards.

• Work alongside Regulatory Affairs to ensure that the correct and complete packages are secured within the established timelines.

• Partner with Contract and Legal to gather feedback on proposed site and investigator contract language.

• Serve as the primary contact for sites to obtain feedback regarding budget and contract negotiations.

• Collaborate with the Project Manager to provide sites with the recommended study budget and negotiate within pre-approved limits.

• Maintain a site intelligence tracker with data related to specific study site requirements, including start-up timelines, budget, contract negotiation timelines, prerequisites, and patient recruitment data.

• Contribute to the suggested site list during start-up based on past experiences with potential study sites.

• Act as the main liaison for study sites throughout the start-up process.

• Cultivate and sustain relationships with study sites to facilitate the timely completion of start-up activities.

• Collaborate with project management and CRAs to plan start-up actions and provide anticipated SIV dates for individual sites based on previous start-up metrics and regulatory and IRB timelines.

• Monitor the progress of start-up activities in smart sheet and/or CTMS.

• Stay informed and ensure compliance with local regulatory requirements and associated documentation.

• Provide project management support with study-related activities as needed.

⛳️ Requirements

• Undergraduate university degree (Bachelor or Honors Bachelor) with minimal training (brief orientation or introductory training); less than 1 year of related experience;

• Or College Diploma/Degree and 1-3 years of relevant experience with initial and ongoing training.

• Exceptional communication skills.

• Awareness of start-up requirements for clinical sites.

• Experience working directly with clinical study sites through previous study involvement.

• Strong sense of urgency.

• Some financial responsibility (handling small cash floats, minimal spending limits, able to provide input during department budget creation).

• Ability to set personal pace and content (significant scope for determining pace and action order within the context of tasks to complete).

• Frequent interactions with a large number of regular contacts (team/unit members, vendors, clients), occasionally challenging, requiring patience and tact.

• Proficiency in both English and French.

🏝️ Benefits

• Accommodations for job applicants with disabilities are available upon request.