ICON Strategic Solutions Looking for Clinical Trial Manager at Canada Full Time

Under the direction of the Clinical Study Manager Group Head, or equivalent, the Clinical Study

Manager is accountable for the day to day planning, executing and reporting, (from site feasibility up to and including study site close-out), of assigned Innovative Medicines Phase I-IV Global Drug Development (GDD) studies in compliance with processes and regulatory requirements.

The CSM is the single point of contact and local study team lead, within the Country/Cluster, for the assigned studies. The CSM is responsible for assuring aligned communication with Country/Cluster Clinical Research Associates (CRAs), CRA Managers and other key Country associates on the execution and progress of their studies.

The CSM is accountable to communicate with and support relationships with clinical investigators. The CSM collaborates with Country medical/clinical trial colleagues on the execution and delivery of their assigned studies.

What you will be doing:

• Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.

• Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.

• Ensure sites are prepared for “Ready to Initiate Site” (checkpoint). Obtain written confirmation about availability of global documents.

• Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.

• Provide training as needed for monitors and any other activities that support site readiness to recruit.

• Ensure documentation of training (global/regional/local IM minutes, participants’ lists, certificates, etc.) is archived appropriately.

• Drive the conduct of the trial, track and oversee progress and status.

• Ensure all operational aspects are on schedule.

• Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues. Appropriately escalate issues in a timely manner and ensure resolution.

• Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.

• Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.

• Track trial budget with appropriate trial budget responsible in country. Oversee TCF preparation and submission to COM in collaboration with the TCF specialist in the countr

• Keep oversight of country level data management activities, including timely resolution of data entry issues, screen failure reasons, discontinuation rates, patient profiles, and proactively identify data entry issues to mitigate queries.

• Accountable to keep reporting systems up to date: ClinAdmin, TMF, CREDI… throughout trial conduct

• Ensure that all trial closeout activities are performed, in close cooperation with field monitors and clinical trial head.

• Oversee local vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required.

• Facilitate internal audits and HA inspections as required.

You are:

• Minimum 5 years’ experience in clinical research in a role, including project management and/or monitoring clinical trials

• Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate.• Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel.• In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country/cluster.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.