Clinical Team Lead

About this role

Join us in redefining what it means to work for a CRO.
When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.
Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.
You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.
We are hiring a Clinical Team Lead! This is a permanent role to work remotely, with the expectation of occasional travel for site visits and client meetings.
The Clinical Team Lead (CTL) is responsible for managing and maintaining ownership of the clinical operations aspects of assigned projects. This position is responsible for providing direction and training to CRAs assigned to the project. In addition, the CTL is responsible for the oversight of all operational aspects related to the planning and oversight of CRA and site performance. The CTL is responsible for ensuring that 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
Requirements
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…