Clinical Study Manager

Alliance for Clinical Trial in Oncology Foundation•Chicago, IL

About The Position

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.

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

Nice To Haves

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%

Responsibilities

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
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