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.

The Alliance for Clinical Trials in Oncology Foundation is looking for a Clinical Study Manager who is excited to lead project and clinical study management. This position will allow you to have hands-on participation in 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. We are an organization of passionate, team-oriented professionals driven to change the face of cancer.

BENEFITS:

• 8 weeks of paid time off (including PTO, sick, and holidays) during year one
• Medical, Dental & Vision plans with 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 AND 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, and 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

Qualification & Education

• 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 preferred
• Demonstrated project management skills; meeting project timelines and budgets preferred
• Assisted in trial design, planning and implementation – initiation through completion
• Solid understanding of the drug development process including GCP and FDA Code of Federal Regulations required
• 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.