Clinical Operations

• 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 Project Manager II – Oncology, Gynecologic Malignancies

• 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 (sites, vendors, committees)
• Support achievement of study milestones and clinical objectives

Clinical Project Manager II – Oncology, NSCLC

• Lead and manage global Phase I clinical trials from study start-up through database lock and closeout with minimal oversight
• Serve as the operational lead responsible for driving study execution, timelines, deliverables, risks, and overall trial performance
• Partner cross-functionally with Clinical Operations, vendors, study teams, and stakeholders to ensure seamless trial execution across all phases of the study lifecycle
• Maintain close oversight of study details, proactively identifying operational gaps, risks, and delays before they impact timelines or quality
• Manage vendors closely to ensure accountability, quality deliverables, budget adherence, and successful execution against study expectations
• Drive study team meetings by developing agendas, facilitating discussions, documenting decisions, and ensuring follow-through on action items
• Navigate fast-paced, high-visibility environments with the ability to prioritize effectively and adapt quickly to changing business needs
• Ensure studies remain inspection-ready and compliant with GCP, SOPs, regulatory requirements, and sponsor expectations
• Support issue escalation and resolution while maintaining strong stakeholder relationships and collaborative team dynamics
• Contribute to process improvement initiatives and operational best practices that enhance study execution and team effectiveness
• Lead with a solutions-oriented mindset while fostering accountability, transparency, and collaboration across teams

Clinical Project Manager II – Virology

• Oversee operational delivery and vendor management activities for early-phase virology clinical trials
• Manage and oversee vendors to ensure quality deliverables, timelines, and study expectations are consistently met
• Coordinate cross-functional clinical trial activities from study start-up through closeout with minimal oversight
• Drive meeting leadership by setting agendas, facilitating productive discussions, documenting decisions, and ensuring accountability for action items
• Partner closely with Clinical Operations, study teams, vendors, and stakeholders to proactively identify and resolve operational challenges
• Ensure effective communication across teams while maintaining professionalism and strong stakeholder relationships
• Monitor study progress, timelines, risks, and operational deliverables to support successful trial execution
• Support inspection readiness and compliance with applicable SOPs, GCP, and regulatory requirements
• Lead with a solutions-oriented mindset while helping align teams toward shared project goals

See all jobs on JobTailor

Clinical Project Manager II – Biomarker Study Management

Clinical Project Manager II – Oncology, Gynecologic Malignancies

Clinical Project Manager II – Oncology, NSCLC

Clinical Project Manager II – Virology

Clinical Project Manager II – Virology