Clinical Study Manager - Chicago, United States - Alliance for Clinical Trial in Oncology Foundation

Description

Job Description

Job Description

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.

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