Manager, Trial Operations

3 weeks ago

Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

Who We Are:
At Xenon Pharmaceuticals (NASDAQ:XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:
We are advancing an exciting pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 Phase 3 program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures. In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study. Xenon's proprietary, pediatric formulation of ezogabine, XEN496, is being studied in a Phase 3 clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway. In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs with valued collaborators. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

About the Role:
RESPONSIBILITIES:

- Provide clinical trial management leadership for one or multiple clinical studies, Phase 1 to 3, as well as multiple secondary assignments.
- 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.
- Assist with the selection of qualified investigators and study sites.
- Oversee study budgets and ensure vendors are invoicing appropriately.
- Develop and manage study timeline and study metrics cross-functionally.
- Conduct risk assessments, mitigation strategies and contingency planning.
- Communicate with internal/external team 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.
- Develop and update 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.

QUALIFICATIONS:

- A bachelor’s degree in a scientific discipline and/or other healthcare designation (e.g., RN).
- A minimum of 5 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.
- Knowledge of Health Authority regulatory requirements and ICH/GCPs
- 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 a part of a multidisciplinary team.
- Exceptional attention to detail and excellent organizational skills.
- Ability to thrive in a dynamic and fast-paced environment.
- Ability and willingness to travel 5-10% of the time (internationally and domestic).

  • Clinical Operations Leader

    1 month ago

    Vancouver, Canada Parexel Full time

    When our values align, there's no limit to what we can achieve.   Clinical Operations Leader / Clinical Trial Manager team members at Parexel average close to 10 years with the company and we are expanding our team. We currently have Home Based Clinical Operations Leader/Clinical Trial Manager positions available in Canada. As the Clinical...

  • Intake & Trial Coordinator

    4 weeks ago

    Vancouver, Canada Rapid Interactive Disability Management Full time

    **Job description** **Medical Legal Intake Coordinator** Rapid Interactive Disability Management (RIDM) is wholly Canadian owned and operated. Formerly known as the Rapid Med Group of Companies, RIDM has been in operation and conducting IME’s since 1986. With extensive coverage across Canada, as well as over 30 years of operational experience in the...

  • Data Administrator, Clinical Trials

    1 day ago

    Vancouver, Canada BC Cancer Full time

    BC Cancer Vancouver, BC The Data Administrator, Clinical Trials performs assigned data management procedures, capturing, and recording clinical trials data, which is performed in accordance with trial protocol, procedures, guidelines, and professional standards of practice. Receives work direction and supervision from the Data Coordinator, Clinical...

  • Clinical Trial Associate 1

    1 week ago

    Vancouver, BC, Canada Xenon Pharmaceuticals Inc. Full time

    Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...

  • Clinical Research and Trials Coordinator

    1 month ago

    Vancouver, Canada PHSA Full time

    **In this role, you will**: - Participate as a part of an interdisciplinary team and coordinate clinical trial activities to ensure that the objectives of the clinical trial are met. - Collaborating with the Qualified Investigator/Principal Investigator, Manager, or designate, assist with preparing documentation required for ethics review and organize...

  • Quality Lead, Clinical Trials

    1 month ago

    Vancouver, Canada PHSA Full time

    **Quality Lead, Clinical Trials** PHSA Corporate Vancouver, BC In accordance with the Purpose, Vision, Values and Coast Salish Teachings, and strategic directions of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is...

  • Clinical Trials Nurse Coordinator, Research Clinical Trials

    22 hours ago

    Vancouver, Canada PHSA Full time

    Clinical Trials Nurse Coordinator, Research Clinical Trials  BC Cancer Vancouver, BC The CTNC functions as a member of the collaborative, interdisciplinary Clinical Trials Team responsible for planning and implementing clinical trials. The CTNC participates in the coordination of clinical trials from the protocol review and approval stage through to...

  • Data Coordinator, Clinical Trials

    19 hours ago

    Vancouver, Canada PHSA Full time

    Data Coordinator, Clinical Trials BC Cancer Vancouver, BC The DCCT functions as a member of the collaborative, interdisciplinary Clinical Trials Team responsible for planning and implementing clinical trials. The DCCT participates in the coordination of clinical trials from the protocol review and approval stage through to activation, trial closure and...

  • Provincial Coordinator, Clinical Trials Training

    4 weeks ago

    Vancouver, Canada UBC Full time

    Staff - Non Union Job Category M&P - AAPS Job Profile AAPS Salaried - Educational Programming, Level A Job Title Provincial Coordinator, Clinical Trials Training Program Department Division of General Internal Medicine | Department of Medicine | Faculty of Medicine Compensation Range $4,826.17 - $6,933.92 CAD Monthly The Compensation Range is the span...

  • Clinical Research and Trials Coordinator

    1 month ago

    Vancouver, Canada PHSA Full time

    **Clinical Research and Trials Coordinator, Radiation Oncology** BC Cancer Vancouver, BC **What you’ll do** - Coordinate, organize and perform special work assignments and projects, including chart reviews, database development and surveys, to ensure the objectives of the assignments/projects are met as directed by the Qualified Investigator/Principal...

  • Data Administrator, Clinical Trials

    22 hours ago

    Vancouver, Canada PHSA Full time

    Data Administrator, Clinical Trials BC Cancer Vancouver, BC The Data Administrator, Clinical Trials performs assigned data management procedures, capturing, and recording clinical trials data, which is performed in accordance with trial protocol, procedures, guidelines, and professional standards of practice. Receives work direction and supervision from...

  • Clinical Trials Nurse Coordinator

    20 hours ago

    Vancouver, Canada PHSA Full time

    Clinical Trials Nurse Coordinator, Research Clinical Trials  BC Cancer Vancouver, BC The CTNC functions as a member of the collaborative, interdisciplinary Clinical Trials Team responsible for planning and implementing clinical trials. The CTNC participates in the coordination of clinical trials from the protocol review and approval stage through to...

  • Provincial Coordinator, Clinical Trials Training Program

    2 days ago

    Vancouver, British Columbia, Canada UBC Full time

    Staff - Non UnionJob CategoryM&P - AAPSJob ProfileAAPS Salaried - Educational Programming, Level AJob TitleProvincial Coordinator, Clinical Trials Training ProgramDepartmentDivision of General Internal Medicine | Department of Medicine | Faculty of MedicineCompensation Range$4, $6,933.92 CAD MonthlyThe Compensation Range is the span between the minimum and...

  • Database Coordinator, Research Clinical Trials

    23 hours ago

    Vancouver, Canada PHSA Full time

    Database Coordinator, Research Clinical Trials  BC Cancer Vancouver, BC The Database Coordinator reports to the Manager, Clinical Trials Unit and establishes, maintains, and improves data quality processes and tools to manage data for clinical trials and research studies in the Clinical Trials Unit. The role ensures consistent and accurate use of...

  • Director or Senior Director Data Management

    5 days ago

    Vancouver, BC, Canada Xenon Pharmaceuticals Inc. Full time €172,600 - €244,500

    Director/Senior Director, Development Program Management We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive...

  • Lead Data Coordinator, Clinical Trials

    59 minutes ago

    Vancouver, Canada PHSA Full time

    **Lead Data Coordinator, Clinical Trials** BC Cancer Vancouver, BC The Lead Data Coordinator for the Health Record Administrators (HRA’s) is charged with providing professional practice leadership and expertise to Health Record Administrators within the agency and is responsible for the daily administration and general supervision of the Data...

  • CRSU Clinical Trials Research Respiratory Therapist

    22 hours ago

    Vancouver, Canada The University of British Columbia Full time

    Job SummaryThis is a senior-level position for registered Respiratory Therapist with a minimum of 10 years of clinical experience in a pediatric hospital setting, and 2 years of experience working in a research capacity. The incumbent will work at the Clinical Research Support Unit at BC Children’s Hospital Research Institute, and may be deployed to...

  • Operations Manager

    5 days ago

    Vancouver, Canada Recycle BC Full time

    The Manager, Post-Collection, is responsible for the operational oversight of the post-collection services for Recycle BC, ensuring the contract is successfully executed and desired outcomes are achieved. This role will manage post-collection operations for the entire Recycle BC reverse supply chain network ensuring successful ongoing operations and...

  • Operations Manager

    5 days ago

    Vancouver, Canada Recycle BC Full time

    The Manager, Post-Collection, is responsible for the operational oversight of the post-collection services for Recycle BC, ensuring the contract is successfully executed and desired outcomes are achieved. This role will manage post-collection operations for the entire Recycle BC reverse supply chain network ensuring successful ongoing operations and...

  • Operations Manager

    4 days ago

    Vancouver, Canada Recycle BC Full time

    The Manager, Post-Collection, is responsible for the operational oversight of the post-collection services for Recycle BC, ensuring the contract is successfully executed and desired outcomes are achieved. This role will manage post-collection operations for the entire Recycle BC reverse supply chain network ensuring successful ongoing operations and...