Study Start Up Specialist (with French)

15 hours, 43 minutes ago
Full-time
Entry Level
Project and Program Management
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986

Description

  • Support Project Management, Regulatory, and Contract and Legal teams in site-related start-up activities.
  • Act as the main Alimentiv contact for study personnel at sites during start-up.
  • Prepare, distribute, and follow up on site start-up documents and executed packages.
  • Review returned site documents for content and correctness against internal standards.
  • Obtain and coordinate feedback on site and investigator contract language with Contract and Legal.
  • Serve as the point of contact for budget and contract negotiations with sites.
  • Maintain site intelligence trackers covering timelines, budgets, negotiation status, prerequisites, and recruitment data.
  • Plan, track, and report on site start-up activities using designated systems such as SmartSheet and/or CTMS.
  • Coordinate start-up planning with project management and CRAs, including expected SIV dates based on timelines and metrics.
  • Ensure compliance with local regulatory requirements and associated documentation while supporting study-related project management tasks.

Requirements

  • Undergraduate university degree (Bachelor or Honours Bachelor) with minimal training and less than 1 year of related experience, or a College Diploma/Degree with 1-3 years of related experience.
  • Excellent communication skills.
  • Knowledge of clinical site start-up requirements.
  • Experience working directly with clinical study sites through previous study involvement.
  • Very high sense of urgency.
  • English and French language skills.
  • Some financial responsibility, including handling small cash floats and minimal spending limits, with input into department budget creation.
  • Ability to manage a large number of regular contacts with patience and tact.
  • Comfort working with significant scope to set personal pace and action order within assigned tasks.
  • Familiarity with regulatory and IRB timelines and documentation (preferred).

Benefits

  • Full-time, permanent employment.
  • Remote/home-based working arrangement.
  • Opportunities to work across multiple European locations.
  • Accommodations for job applicants with disabilities available upon request.
  • A role supporting a clinical study delivery team with direct site engagement.

Interested in this position?

Apply directly on the company website

Apply Now

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