Canopy Cancer Collective ยท 3 hours ago
Clinical Research Program Manager
United States
Full-time
Remote
Senior Level
$125K/yr - $150K/yrCanopy Cancer Collective is a learning health network of leading cancer centers dedicated to improving care and outcomes in pancreatic cancer. The Senior Clinical Research Program Manager is responsible for the overall coordination, management, and execution of clinical research programs and projects, ensuring compliance with regulations and facilitating collaboration among stakeholders.
Health CareMedicalNon ProfitOncology
Responsibilities
Oversee and manage multiple clinical research studies
Develop and maintain project plans, timelines, and budgets
Monitor project progress, identify potential risks and issues, and implement mitigation strategies
Collaborate with the Canopy Cancer Collective Research Governance Committee and the Canopy network to ensure efficient funding and resource allocation across studies
Serve as a central point of contact for all study-related activities
Provide direction and administrative support to the Canopy Research Governance Committee
Collaborate with PIs in the development of study protocols, informed consent forms, and other study-related documents
Assist with budget development for research projects
Manage the regulatory submission process, including IRB applications and approvals
Coordinate site selection and feasibility assessments
Plan and execute study start-up activities, including site initiation visits and training
Ensure adherence to study protocols, GCP guidelines, and relevant regulations
Develop and implement study-specific procedures and tools
Assist in the design of Case Report Forms (CRFs)
Oversee data collection, management, and quality control processes
Coordinate communication between study sites, sponsors, and the study team
Manage and track study supplies and equipment
Facilitate monitoring visits and address any findings
Maintain accurate and complete study documentation (e.g., study files, regulatory binders)
Develop and manage study budgets, track expenses, and ensure financial accountability
Process invoices and payments related to research activities
Collaborate with finance departments and sponsors on budget reconciliation
Maintain a thorough understanding of applicable local, state, and federal regulations, GCP guidelines, and institutional policies
Ensure that all research activities are conducted in compliance with these requirements
Manage the preparation and submission of regulatory documents, including amendments and safety reports
Coordinate and prepare for audits and inspections
Conduct regular team meetings and provide updates on study progress
Liaise with Canopy network sites, partners, and external collaborators (e.g., sponsors, CROs)
Oversee the collection, cleaning, and storage of study data
Generate reports on study progress, enrollment, and data quality
Assist with data analysis and the preparation of manuscripts and presentations
Implement quality control measures to ensure the integrity and accuracy of research data
Participate in quality improvement initiatives
Develop and maintain Standard Operating Procedures (SOPs) related to clinical research activities
Qualification
Required
Background in scientific research or clinical research methodologies is required, experience in clinical trial highly desirable
Strong knowledge of compliance management practices within the context of clinical research
Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements related to clinical trials
Demonstrated project management skills with a track record of successfully delivering projects on time
High visibility projects
Proven ability to collaborate effectively with physicians and healthcare executives to influence clinical decision-making and operational procedures
Excellent organizational skills with the ability to manage multiple priorities simultaneously
Preferred
Experience supervising staff in a laboratory or clinical setting
Strong analytical skills for data collection and interpretation related to clinical outcomes
Company
Canopy Cancer Collective
Canopy Cancer Collective is a non-profit organization dedicated to improving pancreatic cancer treatment and results.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase