Clinical Team Lead II

Clinical Team Lead

Position: Permanent remote with occasional site visits and client meetings.

This role is responsible for managing and maintaining ownership of the clinical operations aspects of assigned projects, providing direction and training to CRAs, overseeing operational aspects related to planning and oversight of CRA and site performance, ensuring sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations.

Responsibilities

• Manages the end-to-end clinical execution of projects up to moderate complexity and scope and/or supports a senior-level CTL on more complex or larger scope projects, ensuring adherence to protocols, timelines, and regulatory requirements
• Oversees recruitment, study metrics monitoring, and documentation activities. With guidance, identifies issues and contributes to implementing solutions
• Ensure sites comply with Good Clinical Practice (GCP) and applicable regulations
• Collaborates with cross-functional teams (e.g., data management, regulatory, safety) to facilitate study deliverables
• Develops and manages clinical operation timelines, metrics, resourcing, budget and activities of projects up to moderate complexity and scope. May also support senior CTLs on more complex or larger scope projects
• Identifies potential risks and escalates to appropriate stakeholders, supporting collaboration and leading implementation of appropriate corrective actions and mitigation strategies
• Manages tracking and reconciliation of clinical budgets related to clinical operation activities such as monitoring visit and CRA allocation. Identifies potential budget variances and escalates to appropriate stakeholders to ensure timely corrective actions are taken and cost-effectiveness is maintained
• May assist with RFP strategic planning, budget development, and capabilities/response narratives
• Performs monthly assessment of CRA resourcing projections based on study parameters (e.g., active sites, projected Days On Site, upcoming milestones, etc.). Works with CRA Line Management to proactively confirm resourcing needs
• Serves as the lead clinical liaison among Clients, site staff, and internal teams on projects up to moderate complexity
• Leads internal and external meetings
• Manages routine Client communications and helps manage client expectations
• Communicates and works effectively with site staff, as needed, serving as an escalation point for CRAs as issues arise
• Leads CRAs and IHCRAs, including project training and onboarding.
• Creates and conducts training sessions including investigator meetings, conferences, and team training
• Provides constructive performance feedback on CRAs/IHCRAs to line managers and project leads
• May participate in Bid Defense Meetings to present clinical operation and monitoring strategy
• Participates in upfront Protocol Deviation planning and identification, in support of finalization and maintenance of Protocol Deviation Plan and related activities
• Manages protocol deviation review and reconciliation throughout the study, ensuring timely documentation and resolution in collaboration with cross-functional teams and Client for review and approval on projects of up to moderate complexity
• Supports the identification and continuous assessment of clinical risks throughout the study and contributes to the development and implementation of risk mitigations on projects of up to moderate complexity
• Provides skilled review and development of study protocols and study-related documents and materials (e.g., clinical monitoring plan, protocol deviation plan, case report forms)
• Oversees and performs on-site Quality Compliance Visits to review data across CRAs using a targeted, adaptive and/or risk-based approach focused on critical and safety related data points. Identifies trends and potential quality issues, escalating as appropriate. Collaborates with CRAs and study teams to implement corrective and preventive actions

Qualifications

• Bachelor's Degree, preferably in a life science, nursing, pharmacy or related field
• 5 years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry
• At least 2 years of experience working as a clinical team lead preferred
• At least 2 years of on-site monitoring experience
• Proven leadership capabilities with experience in leading teams within a CRO or pharmaceutical setting.
• Strong knowledge of GCP and regulatory requirements, as well as familiarity with clinical trial processes and documentation.
• Excellent interpersonal and communication skills, able to build relationships with clients and teams.
• Demonstrated ability to manage multiple priorities and deliver on deadlines in a fast-paced environment.
• A proactive, solutions-oriented mindset with the ability to drive decisions and lead initiatives.
• Experience using clinical trial management software and EDC systems.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.