Project Manager

The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.The Alliance Foundation Trials (AFT) is looking for a Project Manager who manages the development, implementation, and oversight of assigned AFT studies. This role will also interact with pharmaceutical industry partners, vendors, investigative sites and physicians to help AFT studies from activation to closure. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.Benefits of working at the Alliance for Clinical Trials in Oncology Foundation:8 weeks of paid time off (including PTO, sick, and holidays) during year oneMedical, Dental & Vision plans with a 100% employer-paid option for employeesTuition reimbursement stipendsContinuing Education3% employer match for retirement investmentsAnnual Employee Performance Bonus ProgramAnnual Cost of Living Adjustment50% commuter reimbursementHealthy Work/Life balance and flexibilityRequirementsActs as operations lead on one or more AFT studiesServes as primary point of contact between AFT and pharmaceutical industry partners associated with assigned AFT studiesAssists with the design, planning, implementation, conduct, and management of clinical studies from initiation through completionRepresents AFT Clinical Operations on the cross-functional project team, and liaises with medical, statistical, regulatory, quality, and financial personnelManages one or more AFT junior operations staffOversees participating study vendors, including vendor agreements, statements of work, and vendor budgetsManages overall study budget, including approvals of all subject visit payments and vendor invoices for assigned studiesOversees and manages the development of study-related documents together with the scientific team and protocol development team including, but not limited to, study protocol, informed consent forms, laboratory manuals, eTMF plans, etc.Assists in the design, configuration, development, and oversight of study-level systems such as EDC, eTMF, and CTMSOrganizes, schedules, and leads study teleconferences and in-person meetings with investigative sites, physicians, vendors, and consultants as neededServes as the central escalation point for all study issues originating with component groups such as data management, site management, site monitoring, laboratory management, etc., and tracks escalated issues through to resolutionReviews study-related materials including, but not limited to, monitoring reports, key performance metric reports, clinical trial agreements, etc. as neededWorks with the AFT Regulatory Manager to support regulatory filings as neededInitiates and maintains study protocol(s) and associated amendment trackingOversees site activities on assigned studies, including feasibility, activation, accrual, maintenance, and closureTracks study progress and manages clinical timelines, including regulatory document collection, IRB approval, enrollment, management of clinical supplies, etc.Helps build and maintain relationships with site investigators and other site study staffAssists with the reporting of clinical data for regulatory or medical scientific purposes, including study publicationsParticipates in the development and implementation of SOPs and Clinical Operations processes and systemsHandles other duties as assigned.QUALIFICATIONS AND EDUCATIONA minimum of a BA/BS degree is required4-6 years of Pharmaceutical, Academic Research Organization, or Clinical Research Organization research and project management experience requiredWillingness and capability to handle multiple studies and responsibilities with shifting prioritiesDemonstrated project management skills; meeting project timelines and budgetsPrior experience assisting in the design, planning, and implementation of a study from initiation through completionSolid understanding of the drug development process including GCP and FDA Code of Federal RegulationsExcellent organizational, leadership, and problem-solving skillsExcellent written and verbal communication skillsAbility to successfully work both within a team and independentlyExperience working in EDC (RAVE preferred), eTMF, and CTMS systemsProficiency in Microsoft Office applicationsAbility to travel several times a year.Must be authorized to work in the U.S.