Alliance for Clinical Trials in Oncology
Overview
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 interact with pharmaceutical industry partners, vendors, investigative sites and physicians to help AFT studies from activation to closure. Base pay range: $92,500.00/yr - $105,000.00/yr. The actual pay will be based on your skills and experience — talk with your recruiter to learn more. The Foundation is part of the Alliance for Clinical Trials in Oncology and supports cancer clinical research through large-scale clinical trials. Benefits
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, and laboratory management, and tracks escalated issues through to resolution Reviews study-related materials including, but not limited to, monitoring reports, KPIs, 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, and management of clinical supplies Helps build and maintain relationships with site investigators and other site staff Assists with the reporting of clinical data for regulatory or 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 & 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 priorities Demonstrated project management skills; ability to meet project timelines and budgets 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 CFR Excellent organizational, leadership, and problem-solving skills Excellent written and verbal communication skills Ability to work both in 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 Salary Information
The estimated base salary for this position is $92,500 - $105,000. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based on other factors such as relevant skills, experience, and location. Additional
The above statements 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.
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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 interact with pharmaceutical industry partners, vendors, investigative sites and physicians to help AFT studies from activation to closure. Base pay range: $92,500.00/yr - $105,000.00/yr. The actual pay will be based on your skills and experience — talk with your recruiter to learn more. The Foundation is part of the Alliance for Clinical Trials in Oncology and supports cancer clinical research through large-scale clinical trials. Benefits
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, and laboratory management, and tracks escalated issues through to resolution Reviews study-related materials including, but not limited to, monitoring reports, KPIs, 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, and management of clinical supplies Helps build and maintain relationships with site investigators and other site staff Assists with the reporting of clinical data for regulatory or 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 & 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 priorities Demonstrated project management skills; ability to meet project timelines and budgets 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 CFR Excellent organizational, leadership, and problem-solving skills Excellent written and verbal communication skills Ability to work both in 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 Salary Information
The estimated base salary for this position is $92,500 - $105,000. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based on other factors such as relevant skills, experience, and location. Additional
The above statements 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.
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