Clinical Study Manager

The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a nonprofit, tax-exempt 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 GI tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.

Purpose/Scope:

The Clinical Study Manager is responsible for project management and clinical study management of the Alliance for Clinical Trials in Oncology studies. This entails pharmaceutical collaborations involving both NDA-registration and non-NDA-registration trials; managing on-site monitoring for NDA-registration trials; and participating in quality management for assigned trials.

Role & Responsibilities:

Project Management

• Develops detailed project plans, schedules, project estimates, resource plans, and status reports, as appropriate.
• Manages efforts of the project team for assigned clinical trials.
• Assists with the design, planning, implementation, conduct, and management of clinical studies from initiation through to completion.
• Reviews and develops study-related materials including, but not limited to monitoring reports, clinical trial agreements, etc where needed.
• Review budgets and milestones and assist with the development of the related scope of work.
• Identifies, assesses, and recommends selection of vendors where applicable as well as assist with negotiations.
• Works with regulatory compliance and other staff members to assist in maintaining trial status as inspection-ready.
• Identify information/data needed and ensure that they are effectively presented for the marketing approval registration of products worldwide.
• Tracks study progress and timelines, including regulatory document collection, IRB approval and enrollment, management of clinical supplies, etc, as needed
• Participates in the development and implementation of SOPs and study operations processes and systems
• Willingness and capability to handle multiple projects and responsibilities within time constraints
• Serve as the project manager for pharmaceutical collaborations and vendor management, managing multiple aspects of study development and working closely with the program manager, executive officer and other study team members.
• Represents pharmaceutical collaborations on the cross-functional project team and liaises with medical, regulatory, quality, protocol, legal, statistical, data, and financial personnel.
• Serve as primary point-of-contact for pharmaceutical partners.
• Ensure deliverables and milestones are completed according to the agreement
Clinical Study Management

• Works closely with the study teams to implement specific study plans.
• Collaborate with study teams to lead accrual enhancement initiatives, as needed.
• Implement processes to ensure and monitor inspection-readiness by regulatory authorities
• Participates in and conducts visits/meetings with investigative sites, physicians, vendors and consultants as needed
• Helps build and maintain relationships with sites, site study staff to promote the study, enhance accrual and address study management issues.
• Conduct site management while following appropriate procedures to maintain inspection-readiness status.
• Manage Contracted Research Organization for on-site monitoring, as applicable.
• Assist in the development of study-related reports for various purposes.
• Contributes to quality management of trials by maintaining appropriate documentation during the active trial period and participating in the Quality Monitoring Committee.

Requirements

• A minimum of a BA/BS degree is required.
• Degree in a health or science major preferred.
• 3 or more years of Pharmaceutical or Clinical Research experience required
• Project management and site management experience required.
• Technical/medical writing experience is preferred (protocol, IND, ICF, etc.)
• Regulatory documentation; IND preparation and filing experience
• Demonstrated, project management skills; meeting project timelines and budgets.
• Assisted in trial design, planning, and implementation – initiation through completion start
• 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
• Solid computer skills.
• Ability to travel several times a year.
• Fully COVID Vaccinated

Benefits

• 100% employee coverage on select Medical plans + 50% coverage for spouse and children
• 20 Days PTO, 5 Sick Days, 10 Paid Holidays + Winter Break (week off between Christmas & New Year's)
• Tuition & Continued Education Reimbursement
• Employer-sponsored match of 3% to SIMPLE IRA retirement account
• 50% Transit Reimbursement
• Annual Employee Performance Bonus Program
• Annual Cost of Living Adjustment (COLA)
• Career Opportunity Advancement
• Workplace Flexibility & Work/Life Balance