Manager – Trial Operations

Xenon Pharmaceuticals Inc.

Senior Manager, Trial Operations overseeing multiple Phase 3 clinical studies in a biopharmaceutical firm. Collaborating with cross-functional teams, managing vendors, and ensuring compliance in clinical trials.

Posted 5/29/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $140,200 - $195,000 per yearWebsite

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Hard Skills

clinical trial managementstudy managementvendor managementrisk assessmentstudy timeline managementbudget oversightclinical trial protocol writingregulatory document finalizationclinical study life cycledrug development process

Soft Skills

leadershipcollaborationcommunicationinterpersonal skillsorganizational skillsattention to detailprioritizationproblem-solvingmentorshipdiscretion

Certifications & Qualifications

bachelor's degree in scientific disciplineRN (Registered Nurse)

Industry Keywords

Phase 3 studiespharmaceutical industrybiotechnologybiopharmaceutical industryCRO (Contract Research Organization)ICH/GCPUS regulatory environmentCanadian regulatory environmentstandard operating proceduresclinical trial operations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide clinical trial management leadership for multiple Phase 3 studies, across therapeutic areas.
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.
Manage contracted service providers to deliver against the contracts.
Lead the selection of qualified investigators and study sites in collaboration with the Clinical Development team.
Review and oversee study budgets and invoices to ensure vendors are invoicing in accordance with their contracts.
Develop and manage study timeline and study metrics cross-functionally.
Conduct risk assessments, mitigation strategies and contingency planning.
Communicate with internal/external teams 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.
Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
Participate in the development and updating of standard operating procedures as required.

Requirements

What you’ll need

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
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
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 prioritize duties and manage multiple matters from start to finish with minimal supervision
Ability to handle highly confidential and sensitive materials and information with complete discretion
Ability and willingness to travel 5-10% of the time (internationally and domestic)

Benefits

Comp & perks

Our Total Rewards program includes base salary, target bonus, and stock options
Full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs
Employee Assistance Program
Travel insurance
Retirement savings programs with company matching contributions
Time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown
Expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees