Clinical Study Manager

Alliance for Clinical Trial in Oncology Foundation•Chicago, IL

2d•Hybrid

About The Position

The Alliance for Clinical Trials in Oncology Foundation (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. The role involves proactive risk assessment and mitigation, development of project plans, leading cross-functional teams, supporting study development, and managing operational planning and execution from initiation to completion. The Clinical Study Manager will also review study-related materials, support budget development, participate in vendor management, and ensure inspection-readiness for assigned studies. They will track study progress, contribute to SOP development, and handle multiple projects simultaneously. This role serves as the primary point-of-contact for industry partners, ensuring contractual deliverables are met.

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.
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.

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.

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.