Research Operations & Quality Manager

This position function will oversee operations and quality at GTA sites (Hamilton, Mississauga, Toronto, Scarborough), as well as provide backup CRC support (with focus on Toronto and Scarborough).

Additionally, this position will operationally support growth projects, ie.

opening of new locations, implementation of tech systems, initiation of new therapeutic area.

CRP supervision and training :   Support with interviewing and hiring of CRPs across GTA locations  Personnel management of CRCs (3-4) and RAs (1) across GTA locations, including regular 1 : 1 and group meetings  Coordinate and conduct training sessions to support growth and development of CRPs  Quality management & process refinement :   Review IMV follow up letters and coordinate action based on trends detected  Oversee the CAPA process for all identified MPDs  Conduct internal audits as needed  Prepare for and lead the conduct and response to external audits and inspections  Own company-wide adherence to SOPs and GCP guidelines; continually refine and develop the set of SOPs, forms and source templates  Support with source document creation and quality check, where needed  Operations oversight :   Oversee CTMS visit tracking and scheduling across all sites  Regularly run CTMS reports to oversee operations trends and support in evaluation of CRP performance  Have a pulse on eISF and coordinate clean-up efforts where necessary  Identify areas of operational or quality risk and coordinate with leadership on plan of action   Support in study builds within CTMS, where needed  Backup CRC and lab support :    Support where operationally necessary as a backup CRC / lab tech, with focus on Toronto and Scarborough locations  Investigator relationship management :   Regularly touch base with PI’s and SI’s across all sites, incorporating their feedback into our workflows and ensuring frictionless research referrals  Support in the engagement of potential new research investigators, including onboarding them to research through basic training elements  Powered by JazzHR