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Associate Specialist H/F - Québec, QC, Canada - Fopconsultants
Description
Brief description of the position :In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for clinical trial specialist/associate consultants motivated to carry out mandates.
The main missions would be to ensure the compliance of operations, materials, standards, and regulations during the execution of clinical studies.
Main responsibilities:
Without limitation, the main tasks involve:
Support the teams in the execution of clinical trials in accordance with established protocols and procedures and in compliance with regulatory requirements;
Create and maintain clinical study databases and records (eTMF, TMF, etc.) to track the execution of the various projects;
Coordinate the execution of data quality control (QC) activities to ensure the accuracy of information in eTMF/TMF;
Ensures that the necessary equipment and materials are available for the execution of clinical studies;
Prepare minutes in accordance with company procedures and regulatory requirements;
Collaborate with assigned departments to set up confidentiality agreements (NDA, CDA);
Develop or participate in the updating of SOPs;
Maintain a good working relationship with all stakeholders (investigators, suppliers, study personnel, etc.);
Follow up on the progress of clinical studies with external suppliers;
Participate in weekly or monthly meetings on quality assurance files.
Qualifications:
~ Bachelor's or Master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, etc.), or any other related discipline;
~1 (one) to 5 (five) years of industry experience, preferably in the (bio)pharmaceutical sector;
~ Experience in a similar position in clinical research;
~ Experience in TMF/eTMF management;
~ Good knowledge of ICH/GCP standards;
~ Knowledge of regulations (Health Canada, FDA);
~ Proficient in MS Office;
~ Good communication and writing skills in French and English;
~ Mobility (an asset).
Personal skills:
~ Leadership;
~ Rigor et discipline;
~(Organize), able to manage several projects;
~ Analytical and critical mindset;
~ Perseverance;
~ Humility.
What we offer :
In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate.
The main advantages offered are as follows:
Competitive wages;
Group insurance;
Professional insurance;
Remote work, according to the customer needs;
Vacations: 3 weeks;
Paid sick leave: 3 days;
Monthly transportation fees;
Career advancement opportunity;
Continuing education.
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