Manager, Trial Operations – CANADA (Vancouver or Ontario)
The Manager of Trial Operations will work flexibly across a number of clinical stage trials and projects, acting as a study lead and manager for select clinical trials, and be hands-on in data compilation, review and analysis, clinical trial set-up and management, and operational support activities. This is an excellent opportunity for someone with strong organizational skills and the ability to work independently on a variety of tasks and projects. The successful candidate must have strong project management experience, excellent collaboration skills, demonstrate good judgement, be flexible and detail oriented.
The position reports to the Associate Director, Trial Operations and will be located in Vancouver or Ontario.
Provide clinical trial management leadership for one or multiple clinical studies, Phase 1 to 3, as well as multiple secondary assignments.
Collaborate with cross-functional team members to ensure highly integrated plans and documents for clinical trials.
Develop, propose, and manage plans for assigned studies and activities.
Lead the preparation of Requests for Proposals (RFPs) in collaboration with other internal team members, coordinate the evaluation of proposals and provide input into the selection and contracting of Contract Research Organizations (CRO) and other clinical service providers.
Manage contracted service providers to deliver against the contracts.
Assist with the selection of qualified investigators and study sites.
Oversee study budgets and ensure vendors are invoicing appropriately.
Develop and manage study timeline and study metrics cross-functionally.
Conduct risk assessments, mitigation strategies and contingency planning.
Communicate with internal/external team to proactively recognize challenges and work cross-functionally on strategies to mitigate/resolve.
Actively participate in all aspects of clinical trial operations, including the coordination, writing, review and/or finalization of clinical trial protocols, consent forms, case report forms, study plans, safety reviews and other essential regulatory documents.
Train and mentor new staff or peer mentorship of new hires.
Actively participates in documentation, sharing and implementation of trial conduct best practices and lessons learned with junior staff.
Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
Develop and update standard operating procedures as required.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics.
Other duties as assigned.
A bachelor’s degree in a scientific discipline and/or other healthcare designation (e.g., RN).
A minimum of 5 years clinical project/study management experience within the pharmaceutical and or biotechnology/biopharmaceutical industry or at a CRO.
Ability to lead cross-functional team through all activities in the full clinical study life cycle.
Strong vendor management skills and experience managing outsourced work.
A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas.
Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.
Knowledge of Health Authority regulatory requirements and ICH/GCPs
Excellent oral and written communication skills.
Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.
Ability to work both independently and collaboratively as a part of a multidisciplinary team.
Exceptional attention to detail and excellent organizational skills.
Ability to thrive in a dynamic and fast-paced environment.
Ability and willingness to travel 5-10% of the time (internationally and domestic).