Manager or Senior Manager, Clinical Operations
[ January 28, 2020 ]
We are seeking a Manager or Senior Manager, Clinical Operations to join our team. The position may be in either our Vancouver, BC, Canada office, in Boston, Massachusetts, USA, or remote from a home office.
Reporting to the Director, Clinical Operations, the Manager or Senior Manager, Clinical Operations will work flexibly across a number of clinical stage trials and projects, acting as a project 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 simultaneously. In addition, the successful candidate must have strong project management experience, good judgment, be flexible when different tasks arise, and be detailed oriented.
RESPONSIBILITIES:
- Provide clinical trial project management leadership for multiple clinical projects, Phase 1 to 3, and multiple secondary assignments, such as compiling and evaluating literature
- Collaborate with Clinical Science, Biometrics, Regulatory, Medical Writing, Clinical Supply and Development Program to ensure highly integrated cross functional project plans for clinical trials
- Develop, propose and manage plans (including budgets and timelines) for assigned studies and activities
- Lead the preparation of Requests for Proposals in collaboration with other internal team members, coordinate the evaluation of the 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 contract
- Assist with the selection of qualified investigators and study sites
- 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
- Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice
- Develop and update standard operating procedures as required
- Other duties as required from time to time
- Travel for meetings, conferences and other business, as applicable
- Strictly adhere to all Xenon corporate policies as amended from time to time, particularly those concerning confidentiality, intellectual property and safety
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
- Experience within the CNS therapeutic area preferred
- 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.)
- 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 and having good judgment in working with clients, and occasionally under ambiguous or challenging circumstances
- Ability to travel internationally
To apply for this position, please e-mail your resume and cover letter to careers@xenon-pharma.com and include “Manager or Senior Manager, Clinical Operations” in the subject line. Please save any attachments as one file and be named: “Your Full Name – Manager or Senior Manager, Clinical Operations”. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.