Senior Manager, Trial Operations

Xenon Pharmaceuticals•Needham, MA

2d•Hybrid

About The Position

We are seeking a Senior Manager, Trial Operations to join our team. This person may work flexibly across a number of clinical stage trials and projects, acting as a study lead and manager for select clinical trial 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. In addition, the successful candidate must have strong project management experience, excellent verbal and written communication, an ability to work collaboratively, demonstrate good judgement, and be flexible and detail oriented. This position reports to the Director, Trial Operations and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Requirements

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. Job level will be commensurate with experience.
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 (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.), with specific experience in phase 1 and phase IV clinical trials preferred.
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; a comprehensive understanding of clinical trial regulations across multiple jurisdictions with previous experience with CTA and IND submissions preferred.
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 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)

Nice To Haves

Experience in Phase I and Phase IV study conduct preferred
previous experience with CTA and IND submissions preferred

Responsibilities

Provide clinical trial management leadership for multiple Phase 1 and 4 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, 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.
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.
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.
Participate in the development and updating of 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.