Benefits
- Commitment to work-life balance
- Disability insurance
- Floating leave days
- Insurance
- On-going training
- Paid leave
- Paid sick leave
- Performance bonuses
- Reimbursement for public transportation
New
Telecommuting
Clinical Trial Specialists (Sr.)
FOP Experts Conseils inc.
202-9420 Boulevard Taschereau, Brossard,QC- Salary To be discussed
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37.50 to 40.0 h - Full time
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Contract ,Permanent ,Telecommuting job
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Day shift work
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3 positions to fill as soon as possible
Description
POSITION DESCRIPTION
CANDIDATE PROFILE
WORK MODE
WHAT WE OFFER
Read more
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.
KEY RESPONSIBILITIES- 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.
CANDIDATE PROFILE
- 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
WORK MODE
- Remote, Hybrid, On-site
WHAT WE OFFER
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.
Work environment
Equal Opportunity Employer
This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.
Requirements
Level of education
University
Diploma
BAC
Completed
Work experience (years)
10+ years
Written languages
Fr : Advanced
En : Intermediate
Spoken languages
Fr : Advanced
En : Intermediate
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