Provide clinical trial management leadership for multiple Phase 1 and 4 studies, across therapeutic areas
Collaborate with cross-functional team members to ensure integrated plans and documents for clinical trials
Develop, propose, and manage plans for assigned studies and activities
Lead preparation of Requests for Proposals (RFPs) in collaboration with internal team members
Manage contracted service providers to deliver against contracts
Lead selection of qualified investigators and study sites in collaboration with Clinical Development team
Review and oversee study budgets and invoices
Develop and manage study timeline and study metrics cross-functionally
Conduct risk assessments, mitigation strategies, and contingency planning
Communicate with internal/external teams to recognize challenges and collaborate on strategies to mitigate/resolve
Participate in all aspects of clinical trial operations
Train and mentor new staff or peer mentorship of new hires
Oversee adherence to applicable regulations
Participate in development and updating of standard operating procedures
Act in accordance with Company policies

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
Ability to lead cross-functional team through all activities in the full clinical study life cycle, with experience in Phase I and Phase IV study conduct preferred
Strong vendor management skills and experience managing outsourced work
A good understanding of all phases of the drug development process and interdependencies between clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs, etc.)
Demonstrated ability to successfully manage and deliver on critical milestones in the completion of clinical trials on time and within budget
Strong knowledge of ICH/GCP and US and Canadian regulatory environments
Excellent oral and written communication skills
Strong interpersonal skills and ability to foster collaborative relationships with 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
Ability to handle highly confidential materials and information with discretion
Ability and willingness to travel 5-10% of the time (internationally and domestic)

Senior Manager, Trial Operations

Key skills