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
• Contribute 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 updates.
• Provide training of Theradex procedures to staff
• May be assigned as a “Program Manager” for multiple studies under a single Sponsor
• Serves as a mentor and provides guidance to Project Managers, Assistant Project Managers and Clinical Trial Assistants

Study Conduct

• Monitor study enrolment and retention. Act on deviations from plansIdentify 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

• BSc. required – preferably in a life science field or equivalent
• MSc, PhD (preferred)
• PMP Certification(an advantage)

• Healthcare professional with at least 5 years of prior project management experience with demonstrated leadership skills in a CRO/pharmaceutical environment, with a track record in successfully managing clinical trial sites
• Experience of oncology clinical trials and cancer therapies
• Prior experience in a CRO/pharmaceutical environment required

• Core Performance Competencies to high level
• Leadership Competencies to high level
• Completion of Theradex Oncology induction training program, ICH-GCP training
• Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
• Fluent knowledge of written and verbal English
• Knowledgeable of the initiation, conduct, and completion of all phases of oncology clinical trials study endpoints, and clinical databases
• Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems
• Effective in writing reports and varied correspondence
• Effective knowledge of the drug development process and the Theradex Oncology organizational structure
• Effective knowledge of current projects, including:

• Protocol and CRF details
• Study Plans
• Project-specific scientific knowledge
• Sponsor requirements (i.e., Sponsor SOPs, contract-specific requirements, etc.)
• Thorough knowledge of SOPs of Theradex Oncology and specific Sponsor
• Thorough knowledge of current European and North American regulations and any applicable guidelines
• Highly effective ability to set and meet personal short- and long-term goals
• Proficient computer skills of MS Office Suite

• Ability to travel occasionally up to 15% when required, domestic and/or global
• Will need to visit the USA 3 – 4 times per year
• Valid Driver’s License an advantage
• Basic knowledge of one (or more) European language an advantage
• Must be prepared to have an altered work schedule to overlap with the US time-zones i.e. 11:00 – 19:00/20:00
• Must have experience in working internationally
• Must have excellent communication skills