Latest Clairvoyant Therapeutics News
Dec 6, 2021
Life Sciences British Columbia Clinical Operations Manager About our Company: Clairvoyant Therapeutics is a Canadian biotech company focused on psychedelic therapy drug development for addiction. Clairvoyant is at the forefront of a growing psychedelic therapy industry and operates under the principles of open science. Our team has a successful track record of designing and operating clinical trials and bringing new drugs to market. We are a Life Science BC member and pending B Corporation to ensure that we meet the highest standards of verified social and environmental performance, public transparency and legal accountability to balance profit and purpose. To that end, Clairvoyant is excited to add a talented Clinical Operations Manager to the team with a focus on supporting the division leads of the company with various clients. About our Trial: Clairvoyant is launching a phase 2 psilocybin therapy trial in Canada & the EU in alcohol use disorder (AUD) in 2021. Duties & Responsibilities: Ability to set up and initiate the trial efficiently working remotely from a home office 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 randomisation 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 co-ordinating 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, proformed 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. Experience: University degree and a minimum of 5 to 7 years’ related experience in biotechnology/pharmaceutical industry or an equivalent combination of education and experience. Experience managing a Phase 2 Clinical Trial required and experience managing a Phase 3 Clinical Trial preferred Relevant advanced degree including MS, MPH, RN, Ph.D., or US/international MD. Experience in psychology related diseases especially addiction is an asset 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 CTA. NDAs to global authorities 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). Based out of Vancouver, BC, this is an exciting opportunity to expand your project management experience within a biotech venture company with impactful projects. The successful candidate will work remotely for their home office and this will be revisited in Q3 2022. If this sounds like the right fit for you, we look forward to learning more about you. To apply for the role, please submit your resume and cover letter outlining your fit to Damian Kettlewell at firstname.lastname@example.org . Please feel free to contact Damian should you have any questions or require more information.