Clinical Operations

• Responsible for developing, implementing, and monitoring quality assurance and performance improvement (QAPI) programs to ensure the highest standards of patient care and regulatory compliance.
• Oversee clinical outcomes, coordinate quality initiatives, ensure adherence to regulations, and collaborate with the interdisciplinary team to drive continuous improvement in patient safety and clinical quality performance.
• Lead or participate in the clinic’s Quality Assessment and Performance Improvement (QAPI) program in alignment with CMS, state, and organizational standards.
• Develop and implement action plans to address deficiencies and improve care delivery.
• Conduct regular audits and quality reviews to ensure compliance with clinical policies & procedures.
• Facilitate staff education and training related to quality improvement, patient safety, and best practices.
• Collaborate with physicians, nurses, dietitians, social workers, and leadership to support evidence-based clinical initiatives.
• Prepare and present quality reports to clinic leadership and governing bodies.
• Ensure accurate documentation, data collection, and reporting for internal and external stakeholders.
• Promote a culture of accountability, safety, and continuous improvement within the clinic.
• Manage the execution and achievement of Quality key performance indicators (assigned by Quality leadership team) and other clinical initiatives, interventions and standardized education materials with clinic teams within the assigned area(s).

Strategic Clinical Quality Manager - New England Region

• Lead and manage global Phase I virology clinical trials from study start-up through closeout with minimal supervision
• Drive overall study execution, timelines, deliverables, risks, budgets, and operational performance
• Provide oversight and accountability for CROs, vendors, and cross-functional partners to ensure high-quality study execution
• Build strong collaborative relationships with Clinical Operations, Data Management, Regulatory, Medical, Clinical Supply, Biometrics, and other stakeholders
• Lead study team meetings by establishing clear agendas, facilitating productive discussions, documenting key decisions, and ensuring timely completion of action items
• Proactively identify operational risks, develop mitigation strategies, and drive issue resolution before timelines or quality are impacted
• Guide study teams through key transitions across the clinical trial lifecycle while ensuring seamless operational execution
• Maintain oversight of study documentation, trial metrics, operational deliverables, and inspection readiness activities
• Ensure compliance with GCP, SOPs, regulatory requirements, and sponsor expectations
• Foster accountability across study teams while creating an environment of collaboration, transparency, and shared ownership
• Contribute to process improvements and operational best practices that enhance study execution and team performance

Clinical Project Manager II – Virology, Phase I

• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling
• Participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced
• Provide expert operational oversight and guidance to support prioritization of activities
• Assist in recruiting new staff, including participation in interview process and new hire on boarding
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP
• Work closely within appropriate business unit/region to ensure staff performance on studies
• Organize and chair clinical staff meetings at regular intervals
• Facilitate and support project and team/country reviews with Clinical Operations staff

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

• Lead Biomarker Study Operations
• Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs
• Serve as the operational point of contact for all biomarker-related processes
• Work closely with clinical study teams (Phases 1–4) to integrate biomarker strategies into broader clinical development plans
• Plan and manage the collection, tracking, and analysis of biological specimens
• Advise study teams on best practices for sample management and logistics
• Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout
• Ensure studies stay on track with respect to timelines, budget, scope, and quality
• Act as the main liaison between the sponsor and study partners
• Monitor and manage project financials, ensuring fiscal responsibility
• Proactively identify and resolve operational issues and risks
• Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness
• Keep study systems and databases current and audit-ready
• Prepare project reports and updates for sponsors and internal stakeholders
• Plan and facilitate internal and external meetings
• Support inspection readiness and regulatory compliance throughout the project

Clinical Project Manager II – Biomarker Study Management

• Support the Study Lead and cross-functional study team in day-to-day clinical trial operations
• Support activities such as: Clinical Trial Team (CTT) meeting coordination and minutes, Clinical supplies planning and tracking, Lab specimen tracking and reconciliation, Imaging data reconciliation, Study status reporting and updates, Study closeout activities
• Contribute to single or multiple studies, depending on scope and complexity
• Lead smaller or limited-scope studies, as appropriate (e.g., survival follow-up studies)
• Track and manage study timelines using project management tools
• Collaborate with internal stakeholders and external partners, including investigative sites, vendors, and committees
• Support achievement of study milestones and clinical objectives

Clinical Operations jobs in Maine

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Strategic Clinical Quality Manager - New England Region

Clinical Project Manager II – Virology, Phase I

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

Clinical Project Manager II – Biomarker Study Management

Clinical Project Manager II – Oncology, Gynecologic Malignancies