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 andaddress 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 one
- Medical, Dental & Vision plans with a 100% employer-paid option for employees
- Tuition reimbursement stipends
- Continuing Education
- 3% employer match for retirement investments
- Annual Employee Performance Bonus Program
- Annual Cost of Living Adjustment
- 50% commuter reimbursement
- Healthy Work/Life balance and flexibility ROLE & RESPONSIBILITIES
- Acts as operations lead on one or more AFT studies
- Serves as primary point of contact between AFT and pharmaceutical industry partners associated with assigned AFT studies
- Assists with the design, planning, implementation, conduct, and management of clinical studies from initiation through completion
- Represents AFT Clinical Operations on the cross-functional project team, and liaises with medical, statistical, regulatory, quality, and financial personnel
- Manages one or more AFT junior operations staff
- Oversees participating study vendors, including vendor agreements, statements of work, and vendor budgets
- Manages overall study budget, including approvals of all subject visit payments and vendor invoices for assigned studies
- Oversees 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 CTMS
- Organizes, schedules, and leads study teleconferences and in-person meetings with investigative sites, physicians, vendors, and consultants as needed
- Serves 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 resolution
- Reviews study-related materials including, but not limited to, monitoring reports, key performance metric reports, clinical trial agreements, etc. as needed
- Works with the AFT Regulatory Manager to support regulatory filings as needed
- Initiates and maintains study protocol(s) and associated amendment tracking
- Oversees site activities on assigned studies, including feasibility, activation, accrual, maintenance, and closure
- Tracks 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 staff
- Assists with the reporting of clinical data for regulatory or medical scientific purposes, including study publications
- Participates in the development and implementation of SOPs and Clinical Operations processes and systems
- Handles other duties as assigned. QUALIFICATIONS AND EDUCATION
- A minimum of a BA/BS degree is required
- 4-6 years of Pharmaceutical, Academic Research Organization, or Clinical Research Organization research and project management experience required
- Willingness and capability to handle multiple studies and responsibilities with shifting priorities
- Demonstrated project management skills; meeting project timelines and budgets
- Prior experience assisting in the design, planning, and implementation of a study from initiation through completion
- Solid understanding of the drug development process including GCP and FDA Code of Federal Regulations
- Excellent organizational, leadership, and problem-solving skills
- Excellent written and verbal communication skills
- Ability to successfully work both within a team and independently
- Experience working in EDC (RAVE preferred), eTMF, and CTMS systems
- Proficiency in Microsoft Office applications
- Ability to travel several times a year.
- Must be authorized to work in the U.S. PREFERRED SKILLS
- Degree in a health or science major preferred.
- Experience working in oncology research preferred The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all duties and responsibilities associated with it. #J-18808-Ljbffr