Celebrating 40+ Years!

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.   

We are expanding our clinical operations department. This is an exciting opportunity to work within a fast paced, leading global CRO specializing in oncology clinical trials. This position plays a key role supporting and steering various project specific tasks. Our associate project managers interact with internal and external clients, including sponsors, medical monitors, vendors, quality assurance auditors, study investigators and site representatives. 

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

Conducted under the guidance of a Senior Manager: Responsible for project delivery to a quality standard, according to agreed project timeline and budget.

Quality:

• Assist in study-specific oversight plans and ensure adherence and review.
• Ensure protocol deviation meetings are conducted per plan.
• Contribute to internal audit / corrective and preventive action (CAPA) management: contribute to the resolution of CAPA.
• Manage TMF filing of Clinical Operations documentation
• 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:

• Assist with monthly invoice and timesheet review

Clinical Operations:

• Proactive management of clinical projects to ensure issues are identified and solutions established
• Assist with oversight, support and guidance for Theradex study team across departments
• Serve as protocol subject matter expert for assigned study
• Contribute to the development of standard metrics used to routinely monitor study activities
• Assist with day-to-day management of the study team as required, including provision of study training updates.

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

Level of Education:

• BSc. required– preferably in a life science field or equivalent, (includes RN degree)
• MSc. PhD preferred 

Prior Experience:

• Healthcare professional with at least 4 years of clinical experience, or Science Graduate with at least 2-3 years’ experience as a Clinical Research Associate / Senior Clinical Research Associate, with a track record in successfully managing clinical trial sites
• Experience of oncology clinical trials and cancer therapies preferred
• Prior experience in a CRO/pharmaceutical environment preferred

Skills and Competencies:

• Core Performance Competencies to high level
• Leadership Competencies minimal level 
• Completion of Theradex Oncology induction training program, ICH-GCP training 
• 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
• Effective ability to set and meet personal short- and long-term goals 
• Proficient computer skills of MS Office Suite

Additional Requirements:

• Ability to travel in the US up to 30% when required.
• 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.   

Sponsorship or relocation is not offered for this position.

No agencies.