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 - USClinical Project Manager/Sr Clinical Project Manager - Oncology Clinical Trials - GCP - HomebasedTheradex 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 establishedProvide oversight, support, and guidance for the Theradex study team across departmentsServe as protocol subject matter expert for assigned studyContribute to the development of standard metrics used to routinely monitor study activitiesDay-to-day management of the study team as required, including leading team meetings and provision of study trainingProvide training of Theradex procedures to staffAssume other project responsibilities as neededStudy Conduct:Monitor study enrolment and retention; act on deviations from plansIdentify barriers to enrolment; develop and support strategic recruitment and retention solutionsMonitor and act upon study metrics (trend-identification and analysis, with targeted follow up where appropriate)Review Monitoring Visit ReportsEnsure accuracy of study information presented in status reports and clinical trial platformsRisk Assessment & Mitigation:Proactively identify and communicate Clinical Operations risks and mitigations and align with study team on overall Risk Mitigation PlanQuality:Establish study-specific oversight plans and ensure review and adherenceEnsure protocol deviation meetings are conducted per planFacilitate internal audit / corrective and preventive action (CAPA) management, and contribute to the resolution of the CAPAManage TMF filing of Clinical Operations documentationConduct or participate in inspections readiness activities and audits in collaboration with QAContribute as appropriate to Theradex SOPs and management activitiesTimelines:Proactive management of study specific timelines to ensure activities occur as contractedBudget:Review and manage the study budget and scope of work; ensure quarterly budget review meetings are performedWork proactively to ensure the study remains within the agreed scope and budgetInitiate Change Order (CO) activities as requiredConduct monthly invoice and timesheet reviewsWhat 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 preferredHealthcare or industry professional with at least 3 years of clinical/industry experience, or Science Graduate with at least 3 years’ experience as a Clinical Research Associate / Senior Clinical Research Associate, with a track record in successfully managing clinical trial sitesPrior project management experience requiredHigh level of proficiency with Excel and MS Office; ability to master various electronic platforms for data entry and clinical trial managementExperience with oncology clinical trials and/or cancer therapies preferredPrior experience in a CRO/pharmaceutical environment preferredSkills and Competencies:Well-developed critical thinking and analytical skills, with the ability to anticipate problems relating to projects and to develop and implement solutionsAble to seek out multiple and diverse perspectives; open to continuously refining your approach based on feedback and new informationKnowledgeable of the initiation, conduct, and completion of clinical trials, study endpoints, and clinical databasesWell-developed and effective written and verbal communication skills, including report writing, preparing, and delivering presentations, and various correspondence and meeting platformsEffective knowledge of the drug development processWhat 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, short term and long term disability (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.Relocation assistance or company provided sponsorship is not offered for this position.

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