Startup Jobs
Post a Job
Alimentiv
Alimentiv

Manager, Monitoring & Site Management (Canada)

Toronto, Canada
Full-Time
Remote
CAD $99,500 – CAD $166,000 per year

TLDR

Coordinate clinical monitoring delivery, site selection, ICH-GCP compliance, staff development, and contractor services across the project life cycle.

Responsible to plan, manage, organize, evaluate and/or report on the day delivery of the Clinical Monitoring unit (Clinical Operations Leads).

Role includes policy and process development and improvement, product quality, site and compliance monitoring, staff resource planning, and staff and contractor performance management. 

Provide support, expertise and represent project and clinical monitoring teams with sponsors/researchers throughout the project life cycle.

Ensure all team members, including third party providers, deliver high quality, timely service and maintain service delivery processes in accordance with corporate and industry best practices and that meet all regulatory requirements and guidelines.

Project Planning

  • Working in conjunction with clinical monitoring and project leadership team members, identify, develop, plan for, monitor, approve and/or report on project specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, and global project harmonization including SOP and QS document maintenance, periodic site visits and collaborating with IT support to meet sponsor requirements on a timely basis.

    • Customer Service Delivery

  • Represent and support the Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement, to address sponsor/site concerns and to integrate new technologies and processes. 
  • Ensure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceeded.

    • Team Management and Engagement

  • Manage members of the Clinical Monitoring teams, ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to staff in the areas of work allocation, resource planning, training and development, technology, process development, expense management, employee engagement and performance management (staff role development, evaluations, performance improvement and lost time management).

    • Third Party Contract Management

  • Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services, including needs assessment, recruitment, contract negotiations, Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management, ensuring corporate, industry and regulatory service level, guidelines and regulations are maintained.

    • Product/Service Delivery Support

  • Provide expertise, developing tools to support project teams and business development in the areas of clinical, site and compliance monitoring and performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors.

    • Qualifications

  • The successful candidate should have a College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation) and a minimum of 4-6 years related experience + substantial on-going training.
  • Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting.
  • Ability to work in a remote global capacity
  • Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP.
  • Team player that has a customer service approach and is solution oriented.
  • Demonstrated leadership skills
  • Strong verbal, written, and organizational skills.
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment.

    • Working Conditions

  • Home-based

    • PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. 

    Benefits

    Home Office Stipend

    Home-based

    Remote-Friendly

    Ability to work in a remote global capacity

    Alimentiv
    Alimentiv

    Alimentiv delivers specialized clinical research and data services to the healthcare sector, with a strong emphasis on quality assurance and compliance. Our innovative solutions cater to the pharmaceutical and biotechnology industries, accelerating biomarker and drug development through our state-of-the-art lab and clinical imaging software.

    Founded
    Founded 1986
    Employees
    500+ employees
    Industry
    pharmaceuticals
    Biotech Cybersecurity Enterprise Software
    View company profile
    Manager