Senior Manager, Trial Operations
$140,700–$140,700 year
HybridVancouver, British Columbia, Canada or Burnaby, British Columbia, Canada
Job Summary
Lead clinical trial management for multiple Phase 3 studies, overseeing activities from start-up through closeout. Collaborate with Clinical Development, Science, CMC, and Regulatory Affairs to drive strategy, manage RFPs, and select CROs and investigators. Develop study plans, budgets, and timelines while conducting risk assessments and mitigation strategies. Manage contracted providers, review invoices, and oversee adherence to ICH/GCP and regulatory guidelines. Coordinate protocol, consent form, and safety document preparation; train staff and implement best practices. Work cross-functionally to resolve challenges and deliver milestones on time and within budget. Requires 5-8 years of Phase 3 trial operations experience. Hybrid schedule with two onsite days per week; 5-10% travel.
Required Qualifications
- A minimum bachelor's degree in a scientific discipline and/or other healthcare designation (e.g., RN)
- A minimum of 5-8 years clinical project/study management experience within the pharmaceutical and/or biotechnology/biopharmaceutical industry or at a CRO
- Strong proven experience in trial operations oversight, rollout for Phase 3 studies in related therapeutic areas
- Ability to lead cross-functional team through all activities in the full clinical study life cycle
- Strong vendor management skills (including CRO) 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 (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.), with specific experience in phase 3 clinical trials
- Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities
- Demonstrated ability to successfully manage and deliver on critical milestones in the successful completion of clinical trials on time and within budget
- Strong knowledge and understanding of ICH/GCP and US and Canadian regulatory environments
- 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 part of a multidisciplinary team
- Exceptional attention to detail and excellent organizational skills
- Ability to thrive in a dynamic and fast-paced environment
- Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision and with a demonstrated ability to lead change and make independent decisions
- Ability and willingness to travel 5-10% of the time (internationally and domestic)
- This is a Hybrid position requiring a minimum of two onsite days per week
Desired Qualifications
- previous experience with CTA and IND submissions
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