Study Start Up Specialist (with French)

About the Role

Support Project Management, Regulatory, and Contract & Legal teams in all site-related start-up activities. Establish relationships with study personnel at sites and act as the main Alimentiv contact during site start-up. Prepare, distribute, and follow up on start-up documents with sites. Plan and track site start-up activities and data using designated systems and tools. Provide reports on intelligence and metrics related to study start-up activities.

Role and Responsibilities

1. Site Start-Up Packages

• In cooperation with Project Management, create study-specific start-up document packages.
• Distribute and follow up with sites to obtain required executed documents.
• Review the content and correctness of returned documents from sites, in accordance with internal standards.
• In conjunction with Regulatory Affairs, ensure correct and complete packages are obtained within planned timelines.

2. Site Contract and Budget Negotiation

• In cooperation with Contract and Legal, obtain feedback on suggested site and investigator contract language.
• Act as the main point of contact for sites to obtain feedback on budget and contract negotiations.
• In conjunction with the Project Manager, provide sites with the suggested study budget and negotiate within pre-approved margins.

3. Site Intelligence Tracking

• Maintain a site intelligence tracker with data related to specific requirements for study sites, such as start-up timelines, budget, contract negotiation timelines, prerequisites, and patient recruitment data.
• Provide input for suggested site lists during start-up, leveraging past experiences with potential study sites.

4. Site Start-Up Planning and Tracking & Project Management Support

• Act as the main contact for study sites during start-up.
• Develop and maintain relationships with study sites to facilitate timely completion of start-up activities.
• In conjunction with project management and CRAs, plan start-up actions and provide expected Site Initiation Visit (SIV) dates for individual sites based on previous start-up metrics, as well as regulatory and IRB timelines.
• Track progress of start-up activities in Smartsheet and/or CTMS.
• Maintain up-to-date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
• Provide support to project management with study-related activities as required.

Qualifications

• Undergraduate university degree (Bachelor or Honors Bachelor) with minimal training (brief orientation or introductory training) and less than 1 year of related experience; OR College Diploma/Degree with 1-3 years of related experience with initial and ongoing training.

Other Requirements

• Excellent communication skills.
• Knowledge of start-up requirements for clinical sites.
• Experience working directly with clinical study sites through previous involvement in studies.
• Very high sense of urgency.
• Some financial responsibility (handling of small cash floats, minimal spending limits, can provide input during department budget creation).
• Ability to set personal pace and content (significant scope for setting pace and action order within the context of tasks to complete).
• Large number of regular contacts (team/unit members/vendors/clients, occasionally difficult, requiring patience and tact).
• English and French language skills.

Working Conditions

• Home-based.

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