Clinical Trial Specialists (Sr.)

FOP CONSULTANTS is looking for Clinical Trial Specialists at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to coordinate the operational conduct of clinical trials, from document preparation to site close-out and to track recruitment and data, maintain the TMF and ensure compliance with GCP (ICH E6) and Health Canada requirements. The senior scope is further to define the study operational strategy and the monitoring plan and to mentor intermediate consultants and review their deliverables.

• Coordinate the operational activities of clinical trials from site selection to close-out.
• Prepare trial documents: protocols, consent forms and manuals.
• Support submissions to ethics committees and regulatory authorities.
• Track recruitment, data collection and investigational product management.
• Maintain the trial master file (TMF/eTMF).
• Ensure compliance with GCP (ICH E6) and Division 5 of the Food and Drug Regulations.
• Collaborate with investigators, CROs and clinical monitors.
• Define the study operational strategy and the monitoring plan.
• Mentor intermediate consultants and review their deliverables.
• Manage relationships with investigator sites and ethics committees.

• Bachelor's or Master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, etc.), or any other related discipline.
• Minimum ten (10) years of industry experience.
• Eight (08) to fifteen (15) years of experience as a Clinical Trial Specialist.
• Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
• Tools and systems: MS Office suite, Medidata Rave, Veeva CTMS, REDCap, eTMF.
• Hold one of the following certifications: GCP (ICH E6), ACRP CCRC, SOCRA CCRP.
• The following are considered assets: PMP, ACRP CCRA, biostatistics training.
• Experience in Canadian public or private organizations.
• Language: French and English

• Remote, Hybrid, On-site

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

• Competitive compensation that reflects your expertise;
• Complete protection through our group insurance plans;
• Professional liability insurance so you can practise with confidence;
• Remote-work flexibility, based on client needs;
• 3 weeks of vacation to recharge;
• 3 paid sick days, to take care of yourself;
• A monthly allowance for your transportation costs;
• Real opportunities for advancement within the organization;
• Ongoing access to training to grow your skills.