Clinical Operations Lead - Toronto, Canada - Alimentiv

Alimentiv

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

JOB TITLE:
Clinical Operations Lead

JOB LOCATION:
Canada

JOB SALARY:73, ,000 + Bonus

JOB REPORTS TO:
Manager, Monitoring & Site Management

JOB DEPARTMENT/UNIT NAME:
Monitoring & Site Management

JOB SUMMARY:

Responsible for the clinical operations of a project within a defined regional/global level.

Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.

The Clinical Operations Lead acts as a primary liaison between the CRAs and the clinical project team.

Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation, oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.

The Clinical Operations Lead will develop study tools for sites and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

AREAS OF RESPONSIBILITY:

Project Oversight

Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
Monitoring support visits (Comonitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
Oversee regional startup and feasibility activities.
Assist in vendor management activities as required per project.
Perform review of visit reports for quality, compliance and appropriate site management.
Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
Contribute to financial project management processes as applicable. May include but not be limited to input on revenue recognition, site payments, and site passthrough expense review.
May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.

Project Liaison

Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
Provide operational support and guidance to the monitoring team throughout project.
Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
First point of contact for regional CRAs for studyspecific questions and issues. Escalates to PM and other functions as appropriate.
Support line managers by providing status updates on utilization and performance of CRAs.
Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.

Study Documents and Plans

Develop training materials and study tools for sites and CRAs, including monitoring plans.
Develop and implement enrolment and recruitment strategies together with clinical project team.
Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.

QUALIFICATIONS:

WORKING CONDITIONS:

Office/home-based