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Clinical Research Quality Manager
4 months ago
TMG is a national clinical research Site Management Organization (SMO) that has pioneered the representation of private practice physicians in the conduct of clinical research trials. Since 1995 TMG has been training physician investigators and study coordinators in proper research conduct and facilitating their participation in phase II – IV pharmaceutical drug development trials. The success of our organization depends upon the quality and performance of the investigators we represent - they must continually meet or exceed the expectations of pharmaceutical sponsors. As the Clinical Research Quality Manager, you will be responsible for the training and overall quality of TMG investigators and coordinators.
Responsibilities
o Review, update, distribute & track TMG site Standard Operating Procedures (SOPs)
o Develop training methods for TMG sites on SOPs/GCP
o Train new TMG investigators and study coordinators on HC Division 5, ICH GCP conduct, & adherence to TMG SOPs
o Conduct &/or administer QA visits at TMG sites
o Manage QA visit report results for meaningful follow-up action
o Mentor site study coordinators on GCP conduct processes
o Manage new TMG initiatives on quality assurance
o Assist TMG sites in the drafting of Site-Specific SOPs, CAPAs
o Train & promote compliance of TMG sites in good data management in accordance with ALCOA+ principles
o Attend industry conferences on QA implementation for investigators/sites
Draft & update source document worksheets for TMG sites
Qualifications
The Quality Manager will be TMG’s expert on ICH GCP, site SOPs, and all matters concerning site performance. The position will require approximately 10-20% travel to research sites where training, QA, and troubleshooting will take place. You must have the ability to lead experienced, well-trained research professionals to higher performance standards by sharing your own passion for learning and for clinical research, while in turn learning from successful sites which of their processes have most contributed to their success. External liaison with our pharmaceutical partners to communicate our dedication to quality research and to resolve site management issues is an important part of your role. You must be detail-oriented and have excellent organizational and communication skills. You must be self-motivated with the ability to work independently while managing multiple responsibilities.
Interested applicants should have a minimum of 5 years of industry experience as a Clinical Research Associate (CRA) or similar quality assurance role. Proficiency in MS Office is required. Proficiency in French is an asset. Prior experience as a Clinical Study Coordinator is an asset.
