Manager, Clinical Monitoring (EU)

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. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

We are currently seeking a Manager, Clinical Monitoring (EU) to join our team! In this role, you will be responsible for overseeing the clinical monitoring team within Europe, ensuring that clinical monitoring activities adhere to regulatory standards, protocols, and Rho's quality expectations. You will manage a team of Clinical Research Associates (CRAs) and collaborate closely with the Clinical Trial Operations leadership to achieve project objectives. This is an exciting opportunity for you to make a significant impact on clinical trial outcomes by optimizing monitoring processes, fostering a culture of continuous improvement, and supporting your team's professional growth.

What you’ll be doing:

• Direct report / functional management responsibilities for CRAs; meet routinely (at least twice monthly) with employees to provide mentorship and support, as well as discuss development and performance.
• Maintain retrospective and prospective vigilance of utilization, realization, availability to take on additional work and paid time off.
• Support the assessment of clinical monitoring employee resources and employee resource projections to ensure that project teams meet client expectations and contractual obligations.
• Report monthly on CRA staffing development progress, projections, gaps and potential needs, highlighting key areas of accomplishments, metrics and risks.
• Support the CRA Field Assessment process and associated procedural documents.
• Perform periodic monitoring field assessment visits of CRAs to assess GCP/ICH knowledge and compliance in practice and to ensure continued level of optimal performance.
• Supplement assessments by proactively seeking input from appropriate project managers and CTLs as to project-specific performance.
• Provide dynamic mentorship in all aspects of clinical monitoring; serves as escalation point and technical expert for employees and clients as needed.
• Collaborate with project teams to ensure customer satisfaction, high quality deliverables, and profitability for all clinical monitoring projects.
• Determine level and type of clinical monitoring employee resources needed to meet corporate/client/project objectives.
• Interface with staff across projects and functional areas, providing input and feedback to promote quality deliverables.
• May participate in client presentations and/or bid defense meetings as required.
• May participate in Sponsor and Regulatory Authority audits as requested by Quality Assurance (QA).
• Ensure staff fulfills their responsibilities in accordance with policies, procedures, SOPs, ICH-GCPs, and regulatory requirements.
• Participate in quality efforts for continuous improvement by assuring quality metrics are in line with company, client and clinical operations objectives.

Requirements:

• Bachelor’s Degree in life sciences or a related field, along with a minimum of 4 years of clinical monitoring experience in a CRO or pharmaceutical company; previous management experience preferred.
• Strong understanding of GCP, ICH Guidelines, and regulatory requirements within the EU.
• Proficient in clinical trial management and monitoring processes.
• Excellent leadership and people management skills with a proven ability to mentor and develop talent within teams.
• Ability to work collaboratively across various functions and geographies.
• Strong communication and interpersonal skills to effectively liaise with internal teams and external stakeholders.
• Demonstrated problem-solving abilities with a proactive approach to addressing project challenges.
• Ability to manage competing priorities and work efficiently in a fast-paced environment.
• Fluency in English is required; additional language skills relevant to EU countries are a plus.

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.