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Chargé(e) de démarrage de projet / Study Start-Up Associate (Contractor) Canada

9 hours, 1 minute ago
Canada
Contract
Mid Level
Operations Specialist
Project and Program Management
HIPAA
Apply Now
Allucent

Allucent

Allucent is a full-service Clinical Research Organization that specializes in providing high-quality solutions tailored to the unique challenges faced by small to mid-sized biotech firms in the development and approval of new therapies.

Pharmaceuticals
1K-5K
Founded 1994
View All Jobs 5

Description

  • Track assigned start-up activities, milestones, progress, and data in CTMS and other tracking tools.
  • Maintain reliable, current planned milestone dates in CTMS.
  • File owned documents in the electronic Trial Master File and support team members with document filing.
  • Complete site handover to the CRA at the Site Initiation Visit.
  • Prepare, compile, submit, and maintain local IEC/IRB documentation and ethical requirements.
  • Support IEC/IRB communications, including preparing and submitting responses to committee questions.
  • Adapt master informed consent forms to country- and site-specific requirements.
  • Prepare site-specific essential document packages, collect and initially review records, and submit them for independent review.
  • Follow up with sites to resolve essential-document discrepancies.
  • Support feasibility, site identification, clinical trial agreement, budget negotiation, and other business activities as needed.

Requirements

  • Bachelor’s degree in life sciences, healthcare, a related biological discipline, or equivalent education, training, and experience.
  • At least 3 years of experience in drug development and/or clinical research; senior roles require at least 5 years.
  • At least 2 years of experience in a similar CRO or pharmaceutical industry role; senior roles require at least 4 years.
  • Fundamental knowledge of GxP, GDPR and/or HIPAA privacy legislation, and applicable local regulatory requirements preferred.
  • Knowledge of country or regional competent-authority submission processes, reporting requirements, and guidelines.
  • Strong written and verbal communication skills, including good command of English.
  • Ability to work effectively in a fast-paced, challenging environment.
  • Strong organizational, time-management, detail, and accuracy skills.
  • Client-focused, outgoing, and professional approach.
  • Proficiency with Word, Excel, PowerPoint, and similar computer applications.

Interested in this position?

Apply directly on the company website

Apply Now

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