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    Project Manager, Clinical Research - Toronto, Canada - Sinai Health

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    Regular Full time
    Description

    POSITION OVERVIEW

    Provides direct supervision of assigned research staff and manages the administrative responsibilities of a research lab or department, including human resources and finance functions. Interprets implements and ensures compliance with policies, operating plans and processes. In collaboration with the Clinical Principal Investigator forecasts, plans and prepares the department's operating budget; and ensures effective human resource allocation through recruitment, selection, training and performance management.

    DUTIES AND RESPONSIBILITIES

  • Manage and oversee ongoing clinical trial/study operations.
  • Monitor study-wide metrics including recruitment goal attainment and identify related budget issues.
  • Monitor and assure that clinical trial protocol requirements are specifically adhered to, including accuracy of data collection/transcription and daily data transmittal.
  • Identify potential protocol and/or product issues and report back to Investigative Staff and Sponsor for investigation and resolution as needCollaborate with study team and participating sites to ensure targets are met for study start up, site activation, patient or subject recruitment and enrollment and monitor milestones from study launch through closeout.
  • Provide financial oversight of project including budget projections and development and maintenance of tracking systems and tools.
  • Develop, distribute and maintain study-specific regulatory documents including protocol study manuals, SOPs and other study-specific tools and resources. May mentor and supervise staff as necessary.
  • SKILLS/QUALIFICATIONS

  • Bachelor's or Master's degree with 5 plus years of experienceManage and oversee clinical coordinators and technical staff
  • Experience with contract managements with multiple institutes
  • Experience with REB
  • Overseeing Data Base Management and ensuring issues of security and backup
  • Overseeing Biorepository – Cataloguing
  • Maintaining study agreements, service agreements
  • Liaise with collaborators and their institutions
  • Leading development of clinical study initiation with developing SOP's, Consent forms, CRF etc
  • Develop operating budgets and liaise with accounting to support studies
  • Project coordination, program planning, and report development
  • Excellent oral and written communication skills
  • Able to handle multiple tasks as once and have a good understanding of lab priorities
  • Must be accountable
  • Generate and oversee budgets
  • In accordance with Institute's policy and legislated health and safety requirements, employment is conditional upon the verification of credentials, completion of a health review, and demonstrating proof of immunity and vaccination status of vaccine-preventable diseases. All employees and affiliates will follow safe work practices and comply with health and safety policies, procedures, and training. Successful candidates will be required to provide two (2) written reference letters from their former employer(s)/supervisor(s).

    To ensure the safety and wellbeing of all our people and patients, Sinai Health has made it a priority to support everyone in getting vaccinated against COVID-19. Consistent with this, our Staff Immunization & Surveillance Policy was recently updated to include the requirement for full vaccination – currently defined as receiving two doses and serving a 14-day waiting period following the second dose – in order to be able to work at Sinai Health. To be compliant with our updated Policy, you must provide proof of dual COVID-19 vaccination, as indicated on the Prospective Immunization and Surveillance Policy Information Sheet, in order to be eligible for employment at Sinai Health. If you believe you are one of the very few people who may require an exemption from vaccination, supporting medical information must be submitted to our Occupational Health department, who will review and assess.

    We are a fully committed to fairness and equity in employment and our recruitment and selection practices. We encourage applications from Indigenous peoples, people with disabilities, members of sexual minority groups, members of racialized groups, women and any others who may contribute to the further diversification of our Sinai Health community. Accommodation will be provided in all parts of the hiring process as required under our Access for People with Disabilities policy. Applicants need to make their requirements known in advance.

    The Lunenfeld-Tanenbaum Research Institute is a scent sensitive environment, and all members of the community are expected to refrain from wearing or using scented products while visiting or working at the Institute. We also support a barrier-free workplace supported by the Institute's accessibility plan, accommodation and disability management policies and procedures.



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