As a primary point of contact, our project managers are hands-on and interface directly with our sponsors and vendors and cross-functional team members. Our project managers oversee global phase I – III clinical trials startup through closeout to ensure processes, timelines, contracts, ICH/GCP adherence and quality standards are met. They identify and evaluate risks, interpret data on complex issues and implement solutions in order to ensure successful completion of trials.   

The primary responsibilities of this position include, but are not limited to, the following:

Delivery of projects to a quality standard, according to agreed project timeline and budget.

Quality:

• Establish study-specific oversight plans and ensure adherence and review
• Ensure protocol deviation meetings are conducted per plan
• Facilitate internal audit / corrective and preventive action (CAPA) management: contribute to the resolution of CAPA
• Manage TMF filing of Clinical Operations documentation
• Conduct or participate in inspections readiness activities in collaboration with QA
• Contributes as appropriate to Theradex SOPs and management activities

Timelines:

• Proactive management of study specific timelines to ensure activities occur as contracted

Budget:

• Ensure Quarterly budget review meetings are performed, undertake review of budget and scope of work
• Work proactively to ensure the study remains within the agreed scope and budget
• Initiate Change Order (CO) activities as required
• Conduct monthly invoice and timesheet review

Clinical Operations:

• Proactive management of clinical projects to ensure issues are identified and solutions established
• Provide oversight, support and guidance for Theradex study team through across departments
• Serve as protocol subject matter expert for assigned study
• Contribute to the development of standard metrics used to routinely monitor study activities
• Perform day-to-day management of the study team as required, including leading team meetings and provision of study training
• Provide training of Theradex procedures to staff
• Assume Other Project Responsibilities as needed

Study Conduct

• Monitor study enrolment and retention. Act on deviations from plans
• Identify barriers to enrolment and support recruitment and retention strategic solutions
• Monitor and act upon study metrics (review, trend-identification and analysis, with targeted follow up where appropriate)
• Review Monitoring Visit Reports
• Ensure accuracy of information for study presented in status reports (CTMS)

Risk Assessment & Mitigation:

• Proactively identify and communicate Clinical Operations risks and mitigations and align with study team on overall Risk Mitigation Plan