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

• The Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies.
• Act as primary contact and clinical trial expert for assigned study site personnel for execution of the study - including training and coordinating certification of study site personnel and providing technical assistance, as necessary.
• Perform site assessments/site qualification visits in the site selection decision process.
• May participate in and ensure site activation (contracting, IRB/EC/Health Authority approvals are, etc.) are properly obtained, maintained and meet regulatory requirements in collaboration with relevant RDS Functions prior to initiation of the investigational site.
• Develop key study site documents (e.g. Study Monitoring Plan, informed consent documents, source documents, patient instruction guides and case report forms, etc.) and contribute technical expertise in the review of study protocols, data management plans, reports and manuscript, etc.
• Collaborate cross-functionally with R&D, Field Service, Study Management, Biometrics, etc. to deliver best solutions.
• Deliver all data generation/validation and site monitoring activities including end-to-end site visits per relevant regulations and processes.
• May participate in the oversight of CRO delivery of Site Management activities, including training of CRO CRAs. This includes escalation of any issues.
• May work with international investigators and key customers as well.
• May coach colleagues and help others develop expertise/skills
• Accountable for site-level budget of assigned sites
• Work independently and is autonomous

Clinical Site Manager

• 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

• Oversee daily staffing, scheduling, and patient care coordination workflows
• Ensure compliance with clinical protocols, documentation standards, and regulations
• Provide coaching, mentorship, and performance management for nursing staff
• Monitor team performance and implement improvements to enhance patient outcomes
• Collaborate with leadership and cross-functional teams to improve operations
• Support staff development through regular check-ins and training initiatives
• Participate in patient engagement when necessary
• Maintain a positive, inclusive, and performance-driven team culture

Clinical Operations Manager – RN

• Managing mail order operations including oversight of queue management, process development, dispensing accuracy and cross functional team collaboration.
• Developing and implementing clinical pharmacy programs to promote quality and cost-effective drug utilization.
• Assisting in the development of new clinical products.
• Managing clinical pharmacy operations and staff to ensure clients' objectives and deliverables are met.
• Overseeing departmental processes, policies and procedures, training, and communication.
• Ensuring achievement of department goals and objectives.
• Hiring, training, coaching, counseling, and evaluating performance of direct reports.

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Clinical Project Manager II – Biomarker Study Management

Clinical Site Manager

Clinical Project Manager II – Virology

Clinical Project Manager II – Virology

Clinical Operations Manager – RN

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