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 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

Requirements

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.

Alliance for Clinical Trials in Oncology jobs

Project Manager

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