Experience, Rho. A global full-service CRO.
Clinical Team Lead
Location
Spain
Posted
6 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Team Lead
Rho
• Manage 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 • Oversee recruitment, study metrics monitoring, and documentation activities. With guidance, identify issues and contribute to implementing solutions • Ensure sites comply with Good Clinical Practice (GCP) and applicable regulations • Collaborate with cross-functional teams (e.g., data management, regulatory, safety) to facilitate study deliverables • Develop and manage 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 • Identify potential risks and escalate to appropriate stakeholders, supporting collaboration and leading implementation of appropriate corrective actions and mitigation strategies • Manage tracking and reconciliation of clinical budgets related to clinical operation activities such as monitoring visit and CRA allocation. Identify potential budget variances and escalate 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 • Perform monthly assessment of CRA resourcing projections based on study parameters (e.g., active sites, projected Days On Site, upcoming milestones, etc.). Work with CRA Line Management to proactively confirm resourcing needs • Serve as the lead clinical liaison among Clients, site staff, and internal teams on projects up to moderate complexity • Lead internal and external meetings • Manage routine Client communications and help manage client expectations • Communicate and work effectively with site staff, as needed, serving as an escalation point for CRAs as issues arise • Lead CRAs and IHCRAs, including project training and onboarding. • Create and conduct training sessions including investigator meetings, conferences, and team training • Provide 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 • Participate in upfront Protocol Deviation planning and identification, in support of finalization and maintenance of Protocol Deviation Plan and related activities • Manage 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 • Support the identification and continuous assessment of clinical risks throughout the study and contribute to the development and implementation of risk mitigations on projects of up to moderate complexity • Provide skilled review and development of study protocols and study-related documents and materials (e.g., clinical monitoring plan, protocol deviation plan, case report forms) • Oversee and perform 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. Identify trends and potential quality issues, escalating as appropriate. Collaborate with CRAs and study teams to implement corrective and preventive actions
Job 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 systems.
Benefits
- 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.
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