Manager, Translational Research

Job SummaryThe Translational Research Manager is responsible for carrying out the planning, coordination, communication, and conduct of first-in human trials (phase 1) specifically for, but not limited to, Multiple Sclerosis and other central nervous system disorders.The incumbent will play a critical role within a newly established clinical trials team that will build capacity for first-in-human trials. This individual will work closely with clinician-scientists, researchers, as well as research and clinic staff at the Djavad Mowafaghian Centre for Brain Health, and within the broader PHSA community including Vancouver Coastal and VCHRI.The incumbent will bring exceptional organizational skills, as well as a high degree of motivation, enthusiasm and initiative to provide support for first in human clinical trials ensuring compliance with regulatory guidelines, timelines, milestones and budget. This position is integral to carrying out the goals and strategic priorities of the “Research Network”.The incumbent will be directly involved in:1. Developing, writing, and implementation of study protocols, data collection and analysis and budget management;2. Facilitating collaboration with the emerging network of phase 1 clinical trial units within the lower mainland and BC.3. Facilitate collaboration with the VCHRI Phase 1 Clinical Trial Unit at UBC HospitalOrganizational StatusThe MS Clinic situated within the Djavad Mowafaghian Centre for Brain Health takes a multidisciplinary team approach, with neurologists, neuro-ophthalmologists, urologists, nurses, social workers, physiotherapy and occupational therapists, psychiatrists, and genetic counsellors working together to support patient treatment, education and research. Our team also works closely with imaging specialists and basic scientists, all searching for new, innovative ways to diagnose and treat MS.The clinic is a national clinical trial centre for new pharmaceutical therapies; imaging research, advanced genetics and immunology research. Our clinical team is committed to providing the best ongoing treatment, support and provide information for patients with MS and their families. The UBC Hospital MS Clinic is a teaching clinic and is actively involved teaching and mentoring medical students, residents and fellows who may become future MS specialists. All neurologists are affiliated with the UBC Division of Neurology, Department of Medicine, in the Faculty of Medicine.Work PerformedLeads the collaboration betweenthe VCHRI Phase 1 Clinical Trial Unit at UBC Hospital and the Hematology Phase 1 Clinical Trial Unit at Vancouver General Hospital that would meet the needs of the Research Network.Provides leadership in facilitating collaboration with an emerging network of phase 1 clinical trial units within the lower mainland and BC through defining frameworks, advising on protocol implementation, and methodological standards.Designs, evaluates and overseesfirst-in-human trials methodology, feasibility, protocol structure, and risk mitigation, specifically for brain-related illnesses, including trials of cell-based therapiesLeads development of research protocols and logistics to assess and validate biomarkers(e.g., imaging, biological, experimental biomarkers) and other tools required to assess disease progression and measure treatment effectsManages and provides oversight for the full data lifecycle (i.e., recruitment, data collection, data extraction, data cleaning and data analysis). Interprets results to inform research recommendations.Submission of study applications to the research ethics board, Health Canada and other regulatory bodiesEstablishes systems to ensure data is collected according to Good Clinical Practices, compliant with N2 Standard Operating Procedures and Health Canada regulations and standards are followed for all studies with Health Canada approvalProvides expert guidance to industry sponsors, external study coordinators and collaborators on prepare regulatory and clinical documents for manuscript production, monitoring visits, and audits.Responsible for the central management of research activities and budget preparationEngage with researchers across the national/international research ecosystem for collaborative development of shared protocols and data sharing agreementsPursue opportunities to managelocal trials of existing cell-based therapies for MS that are not currently available in BC, such as autologous hematopoietic stem cell transplantation.Maintains ongoing contact with researchers and other collaborators, providing direction, counseling and advice regarding research requirements, protocols and set-upDevelops and updates research case report forms and associated working protocols, and ensure all collaborating sites have up-to-date research information, materials and documentsTrains, supervises and manages research staff associated with the projectCommunicates with and leads collaborations with statistical support staff in determining analytical frameworks and ensuring quality performance of statistical analyses.Ensures effective communication including preparation of written reports and planning, and research administration..Liaises with researchers and other stakeholders working on different aspects of the Research NetworkDevelops progress reports for various stakeholders and conducts preliminary analysis.Provides administrative oversight for research grant proposal including preparing, composing, editing, and proofing related documents. Ensures submissions are completed and accurate.Writes manuscripts and/or drafts of various reports, as neededGives presentations as necessary at lay (community) events and scientific conferences.Performs additional duties as required.​Consequence of Error/JudgementThis position requires working effectively within an organizational structure and involves strong interpersonal skills. Poor decisions and errors in judgment could result in delayed completion of projects or inappropriate planning, result in financial loss, and damage the reputation of the research team.The Research Manager position requires a balance of autonomous, self-directed work as well as teamwork. Works within well-defined guidelines and procedures, but exercises judgment in establishing priorities and carrying tasks through to completion; new or unusual problems are referred to PI.Supervision ReceivedUnder overall supervision of the Principal Investigator with a functional dotted line reporting to the MS Research Network Manager and Associate Director, Research Programs & Administration, FoM. This position works independently and as part of a team.Supervision GivenProvides direction, guidance, and instructions to Research Assistants. Oversees the conceptual and analytic work of the research with the research staff and team.Minimum QualificationsUndergraduate degree in a relevant discipline. Minimum of three years of related experience, or the equivalent combination of education and experience.- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusionPreferred Qualifications· A level of education, training and experience equivalent to a Bachelor’s degree in a health-related science or relevant subject (e.g., Multiple Sclerosis, Neurology, Brain disorders).· Experience in managing clinical trials and studies or the equivalent combination of education and experience. Experience with phase 1 trials an asset.· Thorough understanding of regulatory guidelines including GCP, ICH E.6 R2 guidelines and industry standards.· Ability to communicate effectively verbally and in writing.· Ability to multi-task and maintain an organized and effective personal work environment.· Ability to deal with a diversity of people in a calm, courteous, and effective manner.· Ability to analyze problems, identify key information and issues, and effectively resolve.· Academic library index/database and internet-based research skills.· Knowledge of research ethics applications.· Experience with grant writing.· Experience in using project management tools and concepts including ability to plan and organize, manage timelines, and troubleshoot.· Knowledge of quantitative and qualitative methodology and analysis.· Ability to exercise confidentiality, tact and discretion.· Ability to work effectively independently and in a team environment.· Knowledge of research processes and report writing.· Ability to prioritize and organize work effectively under pressure to meet deadlines with minimal supervision.