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.
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
Proactive management of study specific timelines to ensure activities occur as contracted
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
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
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
BSc. required– preferably in a life science field or equivalent, (includes RN degree)
Msc. PhD. preferred
Healthcare professional with at least 5 years of clinical experience, or Science Graduate with at least 4 years experience as a Clinical Research Associate / Senior Clinical Research Associate, with a track record in successfully managing clinical trial sites.
Prior project management experience required
Experience of oncology clinical trials and cancer therapies
Prior experience in a CRO/pharmaceutical environment preferred
Skills and Competencies:
Core Performance Competencies to high level
Leadership Competencies moderate 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:
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 30% when required, domestic and/or global
Valid Driver’s License an advantage
Basic knowledge of one (or more) European language an advantage
What we offer: We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.
Theradex is an Equal Opportunity Employer.
No agencies please.
Telecommuting is allowed.
About Theradex Oncology
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.
Theradex is an Equal Opportunity Employer