Clinical Project Manager/ Sr Project Manager (Remote)

Who We Are

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.   

What You'll Do

REMOTE - US 

 

Clinical Project Manager/Sr Clinical Project Manager - Oncology Clinical Trials - GCP - Homebased 

 

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

 

What’s in it for you?

Theradex Oncology is a leading global oncology CRO, in business for over 40 years. We support many of the most prominent pharmaceutical and biotech companies in the industry with promising new molecules that address a wide range of oncology indications. We provide a supportive environment through our expertise, innovative systems and processes and we give you the tools to be successful as we grow our Clinical Operations Team.

 

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

 

Clinical Operations:

• Proactive management and execution of clinical projects to ensure issues are identified and solutions established
• Provide oversight, support, and guidance for the 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
• 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; develop and support strategic recruitment and retention solutions
• Monitor and act upon study metrics (trend-identification and analysis, with targeted follow up where appropriate)
• Review Monitoring Visit Reports
• Ensure accuracy of study information presented in status reports and clinical trial platforms

Risk Assessment & Mitigation:

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

Quality:

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

• Review and manage the study budget and scope of work; ensure quarterly budget review meetings are performed
• 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 reviews

What You Need

Requirements:

• Must be fluent in English (verbal and written)
• BS. required– preferably in a life science field or equivalent (includes RN degree)MS. or PhD. preferred
• Healthcare or in