Clinical Study 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 is seeking a Clinical Study Manager. The Clinical Study Manager is responsible for project management and clinical study management for studies ran by the Alliance for Clinical Trials in Oncology. This includes collaborating with Industry Partners for both NDA-registration and non-NDA registration trials; managing on-site monitoring; and participating in quality management of assigned trials.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 flexibility ROLE AND RESPONSIBILITIESProject ManagementProactively identifies, assesses, documents, escalates, and manages study risks and operational issues; develops and implements mitigation and corrective action strategies, as appropriateDevelops and maintains detailed project plans, schedules, project projections, resource plans and status reports, as appropriateLeads and coordinates cross-functional team activities for assigned clinical trials.Supports study development and leads the operational planning, implementation, conduct, and management of assigned studies from initiation through completion.Reviews and supports development of study-related materials including, but not limited to monitoring reports, clinical trial agreements, etc. where neededSupport budget development and related scope of workParticipates in vendor identification, evaluation, selection, and contracting activities, as applicable, and provides ongoing oversight of vendor performance, deliverables, timelinesWorks with Regulatory, Quality, and other staff members to maintain inspection-readiness for assigned studiesCoordinates and maintains relevant study information and records in support of registration objectives, as applicableTrack study progress in reference to projected timelines, established milestones, available budget, accrual goals, and other operational components, as applicableParticipates in the development and implementation of SOPs and study operations processes and systemsWillingness and capability to handle multiple projects and responsibilities in consideration of known time constraintsServe as the project manager for Industry collaborations and vendor management, managing multiple aspects of study development and working closely with the program manager, executive officer and other study team membersRepresents Industry collaborations on the cross-functional project team and liaises with medical, regulatory, quality, protocol, legal, statistical, data management, and financial personnelServe as primary point-of-contact for industry partnersEnsure deliverables are fulfilled according to milestones within the contractClinical Study ManagementAnalyzes study performance metrics and operational data to identify trends, risks, and opportunities for corrective actionProvides oversight and management of site performance, including enrollment/accrual, study conduct, protocol compliance, operational issues, and timely completion of study-related activitiesWorks closely with the study teams to implement specific study plans Collaborates with study teams to lead accrual enhancement initiatives, as needed Implements and monitors processes that support ongoing inspection-readinessParticipates in and conducts visits/meetings with investigative sites, physicians, vendors and consultants as needed Helps build and maintain relationships with site staff in support of the study and address study management issuesConducts site management while following appropriate procedures to maintain inspection-readiness status Provides oversight of monitoring CROs including monitoring performance, reports, deliverables, timelines, quality metrics, issue escalation, and follow-upDevelops and/or contributes to study-related reports, presentations, and status updates for internal and external stakeholdersContributes to study-level quality management by monitoring key performance indicators, identifying and escalating quality concerns, supporting corrective and preventative action plan implementation, maintaining appropriate study documentations, and participating in the Quality Monitoring and Management Committee Requirements Qualifications and Education RequirementsMinimum of a BA/BS degreeMinimum of 3 years of pharmaceutical, biotech, CRO, or site experience in clinical researchStudy Management experience Experience in supporting trial development, implementation, and completionDemonstrated knowledge of the drug development process, ICH-GCP, applicable FDA regulations, and clinical research requirementsProficiency in Microsoft Office programs and business-level computer skillsDemonstrated knowledge of EDC and other clinical systemsPreferred SkillsOncology Research ExperienceExperience using Project Management programs/toolsExperience with CRO/vendor oversight, including performance management and issue escalationStakeholder management Technical/medical writing experience (protocol, IND, ICF, etc.) Experience managing study-specific project plans, budgets, timelines, milestones, and deliverablesExcellent organizational, leadership and problem-solving skills to lead cross-functional activities Excellent written and verbal communication skills Ability to successfully work both within a team and independently Ability to travel <10%.