Clinical Operations Manager
Our client, DESCRIPTION OF CLIENT AND ROLE.
- Assisting in the assessment of potential CRO/third-part vendors for capacity and capability to provide study related services
- Piloting the budgeting and contracting process to add clinical sites to a clinical study
- Development and management of the study Monitoring Plan
- Development of key study tools
- Assistance in collecting all site documentation needed
- Review of all proposed monitors for a project, both initial and replacement
- Responsible for review of study protocols
- Managing the monitor training program for a clinical study; including training at the Investigator Meeting as well as on-site, individual monitor training, as needed
- Site management visits, conducted regularly to ensure site is prepared for the proper execution of the study
- Working with the Clinical Trial Assistant to ensure that all relevant documents are properly archived in the TMF during the study
- Perform co-monitoring visit to ensure monitor performance meets expectations, monitoring is performed as outlined in the approved study monitoring guidelines and monitoring is in compliance with ICH/GCP Guidelines
- Responsible to provide CRO/third-part vendor oversight during study conduct
- Review of site activities and status of inter-related departmental activities, so as to approve and authorize site closure
- Ensure sites are closed appropriately
- Ensure the completeness of the TMF before final archiving in collaboration with the Clinical Trial Assistant and the Lead COM
- A minimum of a Bachelor’s degree in a scientific or health-related field is required; or equivalent experience.
- Minimum five years of experience in the biotech, pharmaceutical, contract research organization arenas; working as a clinical operations manager. Or 5+ years as a monitor, ideally with clinical lead experience
- Demonstrated proficiency in all aspects of clinical monitoring and oversight of contract resources
- Fundamental working knowledge of ICH, FDA and EMEA GCPs
- Excellent organizational, written and oral communication skills in English are required, with multiple languages preferred, including French
If you match the above skill set I look forward to receiving your application, including a motivational letter, via this website.
Please check that your qualifications and experience match the vacancy and that you fill the required criteria. After you have submitted this application form with a current CV, we will endeavour to contact you as soon as we can.
Please submit your CV in Microsoft Word format. We are unable to accept CVs submitted in alternative formats.
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