CLINICAL DEVELOPMENT (CANADA/US)

Clinical Trial Manager (Contract to Permanent)

Novateur is excited to add an experienced Clinical Trial Manager to the team with a focus on supporting the division leads of the company with various clients. For the Clinical Trial Manager role, we are seeking candidates with years of industry experience leading pre-clinical and clinical trials within reputable companies in North America. 

With a head office in Vancouver BC and ability to work remotely from anywhere in Canada or the US, this is an exciting opportunity to expand your project management experience within a biotech venture company with impactful projects globally. If this sounds like the right fit for you, we look forward to learning more about you.

DUTIES AND RESPONSIBILITIES

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  • Ability to set up and initiate trials.
  • The overall efficient day-to-day management of the trial.
  • Ability to manage clinical CROs and clinical trial sites.
  • Recruitment, retention, training, appraisal and supervision of trial team members.
  • Establishment of procedures to ensure adherence to trial protocols and administrative requirements.
  • Ensuring the timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective data management.
  • Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
  • Management of the trial budget(s) and maintenance of the accounts.
  • Act as the point of contact for all external and internal agencies.
  • Co-ordinate the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements.
  • Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes.
  • Liaison with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
  • Provision of regular and ad hoc information, both written and verbal, to all the trial participants and sponsors, to include reports, updates, guidance, preformed commitments and possibly a newsletter.
  • Work with the Principal Investigator(s) to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
  • Ensure the inclusion of consumer group representatives at the appropriate levels and times.
  • Planning and supporting the meetings and work of the various groups and bodies associated with
  • the trial.
  • Creation and maintenance of all trial files, including the trial master file, and oversight of site files
  • Assurance that personal and confidential information is restricted to those entitled to know.
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EXPERIENCE

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  • University degree and a minimum of 5 to 7 years’ related industry experience in biotechnology/pharmaceutical industry or an equivalent combination of education and experience.
  • Relevant advanced degree including MS, MPH, RN, Ph.D., or US/international MD.
  • Experience in either one of these areas is an asset: Oncology, CNS, Bone, Infectious Disease.
  • Prior clinical trial experience in both writing and implementation.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
  • Ideally have had exposure to the development of therapeutics and filing INDs. NDAs preferred. Direct involvement in managing teams to file IND, clinical trials and submission to FDA is preferred.
  • Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
  • Strong attention to detail, combined with an ability to maintain a broad strategic perspective.
  • Understanding of critical path and timeline implications of activity lead, lag, floats.
  • Proven conflict resolution skills, with demonstrated ability to identify issues and to work collaboratively to diagnose problems and generate potential solutions.
  • Proficiency with MS Office, utilization of PM software (MS Project or other Gantting software).
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