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- Tasks: Lead clinical operations for exciting projects and mentor a dynamic team.
- Company: Join Rho, a unique CRO where curiosity and collaboration thrive.
- Benefits: Enjoy remote work flexibility, a supportive community, and opportunities for career growth.
- Why this job: Be part of a culture that values innovation, teamwork, and making a real impact in healthcare.
- Qualifications: Bachelor's degree in life sciences or related field; 6 years of clinical research experience required.
- Other info: This is a permanent role with occasional travel for site visits.
The predicted salary is between 36000 - 60000 ÂŁ per year.
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 II! This is a permanent role to work remotely, with the expectation of occasional travel for site visits and client meetings.
The Clinical Team Lead II will independently manage and maintain ownership of the clinical operations portion of assigned projects. The Clinical Team Lead II will be the primary point of contact to Clinical Research Associates (CRAs) and other Functional Leads for project, and clinical-related issues. This position will be responsible for providing direction to and training CRAs assigned to those projects to ensure compliance and adherence with Protocol, Clinical Monitoring Plan and project specific requirements, ICH GCP guidelines and country specific regulations. In addition, the Clinical Team Lead II is responsible for the oversight of all clinical operational aspects related to the planning and oversight of CRA and site performance and metrics.
Responsibilities
- Lead the clinical operations function for projects of moderate to high complexity and scope and/or provide support to Senior Clinical Team Lead on larger, more complex projects or programs
- Proactively drive project success, by collaborating with cross-functional study leads to develop and implement operational strategies
- Responsible for identification and mitigation of clinical risks, and contributing to the quality risk management process
- Conduct in-depth reviews of study protocols and related materials to ensure clarity, compliance, and alignment with research objectives
- Develop and maintain study-specific clinical operations timelines, performance metrics, and tracking toolsProactively manage study-specific CRA resourcing strategy, and update resourcing projections based on actual observed effort, where necessary. May manage projects of limited complexity and scope in a dual CTL/PL role
- Develop and implement clinical management and monitoring tools and plans (e.g., Clinical Monitoring Plan, Protocol Deviation Plan, Investigator Site File, Site Operations Manual)
- Accountable for clinical operational aspects related to the planning and oversight of site performance and metrics in accordance with departmental productivity expectations
- Support PL on the creation, organization, and maintenance of the Trial Master File (TMF) to ensure comprehensive and timely documentation and compliance with regulatory requirements
- Create and conduct training sessions for CRAs and site staff including investigator meetings and clinical team trainings
- Collaborate with the Study Start Up Lead to drive the study start up process by tracking and reporting progress and reviewing data, ensuring that site selection and study supplies align with study expectations, while activating sites per established timelines
- Oversee and support site feasibility and site selection process in alignment with the study plan
- Provide status updates to project management and sponsors while promoting the use of project dashboards to enhance study status communication with both internal and external stakeholders
- Facilitate and lead both internal and external meetings, including CRA meetings, to promote effective communication and collaboration
- Work effectively with site staff, as needed, serving as an escalation point for CRAs to address and resolve issues as they arise
- Manage clinical site communication and documentation of decisions, including managing mass correspondence to sites regarding study updates
- Review site visit reports and ensure finalization is within contractual timeline
- Review protocol deviations for accuracy, completeness, and ensure all deviations are properly documented. Facilitate the review process for Medical Monitor and sponsor to assess protocol deviations
- May assist Project Managers with project management tasks as assigned
- Support the management and development of In-house CRAs and CRAs
- May support the mentorship and development of junior level CTLs
- May support business development and the Request for Proposal process, leading the development of proposal materials and participation in Bid Defense Meetings
Requirements
- Bachelor\’s Degree, preferably in a life science, nursing, pharmacy or related field (4 additional years of relevant experience could be considered in lieu of a bachelor\’s degree)
- 6 years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry
- At least 2 years of experience leading the clinical operations function within clinical trials
- 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.
Please submit your CV in English. Thank you!
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research
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Clinical Team Lead II employer: Rho
Contact Detail:
Rho Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Team Lead II
✨Tip Number 1
Familiarise yourself with the latest trends and challenges in clinical operations. This will not only help you understand the role better but also allow you to engage in meaningful conversations during interviews, showcasing your knowledge and enthusiasm for the field.
✨Tip Number 2
Network with professionals already working in CROs or similar environments. Attend industry events or join online forums where you can connect with others in the field. This can lead to valuable insights and potentially even referrals for the Clinical Team Lead II position.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led teams or managed projects in the past. Highlight your leadership skills and ability to drive project success, as these are crucial for the Clinical Team Lead II role.
✨Tip Number 4
Demonstrate your understanding of GCP and regulatory requirements by staying updated on any recent changes in the industry. Being able to speak confidently about compliance issues will set you apart from other candidates.
We think you need these skills to ace Clinical Team Lead II
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research and leadership roles. Emphasise your familiarity with GCP, regulatory requirements, and any specific software you've used in previous positions.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company culture at Rho. Mention how your background aligns with their values of curiosity and collaboration, and provide examples of how you've tackled challenges in past projects.
Highlight Leadership Experience: Since the role requires proven leadership capabilities, be sure to detail your experience leading teams within a CRO or pharmaceutical setting. Use specific examples to demonstrate your ability to manage multiple priorities and drive project success.
Showcase Communication Skills: Given the importance of interpersonal skills in this role, include examples of how you've built relationships with clients and teams. Highlight any experience you have in facilitating meetings or training sessions, as this will resonate well with the job description.
How to prepare for a job interview at Rho
✨Show Your Leadership Skills
As a Clinical Team Lead II, demonstrating your leadership capabilities is crucial. Prepare examples of how you've successfully led teams in the past, particularly in clinical settings. Highlight your ability to mentor and develop others, as this will resonate well with the interviewers.
✨Understand the Rho Factor
Familiarise yourself with the company culture at Rho, which values curiosity and collaboration. Be ready to discuss how you can contribute to this environment and share any experiences that reflect these values. This will show that you're not just looking for a job, but a place where you can thrive.
✨Prepare for Technical Questions
Given the technical nature of the role, brush up on your knowledge of GCP guidelines, clinical trial processes, and relevant regulations. Be prepared to answer questions about how you've handled compliance issues or managed clinical risks in previous roles.
✨Demonstrate Problem-Solving Abilities
The role requires a proactive, solutions-oriented mindset. Think of specific challenges you've faced in clinical operations and how you resolved them. Sharing these stories will illustrate your ability to drive decisions and lead initiatives effectively.
