Manager, Clinical Trials

Healthcare

Burlington, ON

  • 2022-01-04
  • Our client is a cutting-edge Canadian clinical-stage profitable organization in the pharmaceutical industry. They are on a mission to innovate pharmaceutical therapeutics and have a facility that includes production and pharmaceutical R&D equipment that is qualified and maintained to GMP standards, which represents the highest standard of quality. They are looking for a Manager, Clinical Trials to join their superb team in Burlington, ON. 

    This is a full-time position that reports to the Vice President, Clinical and Scientific Affairs. This position may also require international and domestic travel up to 15% of the time. 

    General Responsibilities:
    • Oversee and manage external service providers in conducting clinical trials on time, on budget, in compliance, and with the highest quality.
    • Provide operational expertise and input for clinical trials.
    • Provide expertise and operational input into study related documents
    • Identify and communicate lessons learned and implement best practices to promote continuous improvement.
    • Work collaboratively with contracted CRO’s, ensuring all activities are completed with high quality and in accordance with the project plan.
    • Assess CRO timeline and other plans to ensure accurate assumptions are applied and risk management plans are in place.
    • Develop and/or maintain tracking tools for clinical trials, including, but not limited to, site status, enrollment, study and monitoring visits, sample tracking, data entry and review and action items.
    • Review and contribute to study documents including but not limited to site feasibility, and qualification, informed consent documents (site specific), monitoring plans/reports, regulatory and start-up plans, CRF template, patient recruitment plans, project management plan, data management plan, pharmacy and lab manuals and training materials.
    • Ensure all processes and tools are available to maximize enrollment, including, but not limited to a clear recruitment strategy plan, clearly defined contingency plans with agreed trigger points for deployment. Ensure constant review and updated of plans and strategies throughout the study.
    • Partner with the CRO’s Project Management team, to confirm timely delivery of objectives according to agreed-upon contract, strategy and plans. Effectively communicate and assess performance against these agreed objectives.
    • Review outcomes/actions related to protocol deviations review and assess for trends across/within sites.
    • Oversee trial-related supply chain to ensure seamless collection/manufacture/shipment of clinical trial material.
    • Proactively highlight risks that could impact the clinical delivery of the project and recommend mitigating actions. Identify issues, recommend, and follow up on corrective actions to ensure quick resolution.
    • Achieve project quality by identifying quality risks and issues, escalating issues to the VP and propose appropriate corrective and preventative action plans.

    Requirements:
    • B.Sc. or M.Sc. (preferred) in a biomedical, life science, or related field of study.
    • 7+ years of experience of clinical operations or clinical project management experience (combination thereof preferred) in a pharmaceutical and/or CRO setting.
    • 5+ years of experience related to multiple-site phase 2/3 trials.
    • Expert level knowledge and hands-on experience in all aspects the clinical trial process.
    • Expert knowledge of GCPs, ICH guidelines and FDA/Health Canada Clinical Trial regulations.
    • Excellent verbal and written communication skills.
    • Excellent problem-solving skills and keen attention to detail.
    • Strong sense of urgency and experienced in effectively managing multiple priorities under time and resource constraints.
    • Proactive, self-starter, with proven ability to work independently.
    • Ability to foster effective relationships with vendors, investigators, and colleagues.
    • Proficiency with Microsoft office; familiarity with clinical trial-related software (e.g., electronic data capture systems, compliance monitoring systems, e-diary, etc.).

    If you have the above requirements and this sounds like an opportunity for you, send your resume in confidence directly to Bryan Forrest, bforrest@locksearchgroup.com or by clicking the APPLY button!

    Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted. Applicants must be legally entitled to work in Canada without sponsorship.