Clinical Study Manager

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.

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 is seeking a Clinical Study Manager. The Clinical Study Manager is responsible for project management and clinical study management for studies ran by the Alliance for Clinical Trials in Oncology. This includes collaborating with Industry Partners for both NDA-registration and non-NDA registration trials; managing on-site monitoring; and participating in quality management of assigned trials .

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

ROLE AND RESPONSIBILITIES

Project Management

• Proactively identifies, assesses, documents, escalates, and manages study risks and operational issues; develops and implements mitigation and corrective action strategies, as appropriate
• Develops and maintains detailed project plans, schedules, project projections, resource plans and status reports, as appropriate
• Leads and coordinates cross-functional team activities for assigned clinical trials.
• Supports study development and leads the operational planning, implementation, conduct, and management of assigned studies from initiation through completion.
• Reviews and supports development of study-related materials including, but not limited to monitoring reports, clinical trial agreements, etc. where needed
• Support budget development and related scope of work
• Participates in vendor identification, evaluation, selection, and contracting activities, as applicable, and provides ongoing oversight of vendor performance, deliverables, timelines
• Works with Regulatory, Quality, and other staff members to maintain inspection-readiness for assigned studies
• Coordinates and maintains relevant study information and records in support of registration objectives, as applicable
• Track study progress in reference to projected timelines, established milestones, available budget, accrual goals, and other operational components, as applicable
• Participates in the development and implementation of SOPs and study operations processes and systems
• Willingness and capability to handle multiple projects and responsibilities in consideration of known time constraints
• Serve as the project manager for Industry 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 Industry collaborations on the cross-functional project team and liaises with medical, regulatory, quality, protocol, legal, statistical, data management, and financial personnel
• Serve as primary point-of-contact for industry partners
• Ensure deliverables are fulfilled according to milestones within the contract

Clinical Study Management

• Analyzes study performance metrics and operational data to identify trends, risks, and opportunities for corrective action
• Provides oversight and management of site performance, including enrollment/accrual, study conduct, protocol compliance, operational issues, and timely completion of study-related activities
• Works closely with the study teams to implement specific study plans
• Collaborates with study teams to lead accrual enhancement initiatives, as needed
• Implements and monitors processes that support ongoing inspection-readiness
• Participates in and conducts visits/meetings with investigative sites, physicians, vendors and consultants as needed
• Helps build and maintain relationships with site staff in support of the study and address study management issues
• Conducts site management while following appropriate procedures to maintain inspection-readiness status
• Provides oversight of monitoring CROs including monitoring performance, reports, deliverables, timelines, quality metrics, issue escalation, and follow-up
• Develops and/or contributes to study-related reports, presentations, and status updates for internal and external stakeholders
• Contributes to study-level quality management by monitoring key performance indicators, identifying and escalating quality concerns, supporting corrective and preventative action plan implementation, maintaining appropriate study documentations, and participating in the Quality Monitoring and Management Committee

Requirements

Qualifications and Education Requirements

• Minimum of a BA/BS degree
• Minimum of 3 years of pharmaceutical, biotech, CRO, or site experience in clinical research
• Study Management experience
• Experience in supporting trial development, implementation, and completion
• Demonstrated knowledge of the drug development process, ICH-GCP, applicable FDA regulations, and clinical research requirements
• Proficiency in Microsoft Office programs and business-level computer skills
• Demonstrated knowledge of EDC and other clinical systems

Preferred Skills

• Oncology Research Experience
• Experience using Project Management programs/tools
• Experience with CRO/vendor oversight, including performance management and issue escalation
• Stakeholder management
• Technical/medical writing experience (protocol, IND, ICF, etc.)
• Experience managing study-specific project plans, budgets, timelines, milestones, and deliverables
• Excellent organizational, leadership and problem-solving skills to lead cross-functional activities
• Excellent written and verbal communication skills
• Ability to successfully work both within a team and independently
• Ability to travel <10%.