The Opportunity:

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

The Clinical Trial Operations Lead will play a pivotal role in overseeing the end-to-end operations of our US based clinical trials. Reporting to the Head of Clinical Development, this position involves strategic planning, execution, and management of trials while ensuring compliance with regulatory requirements. With line management responsibilities, you will lead a team of clinical operations professionals, fostering their growth and driving operational efficiency. This is a hands-on leadership role ideal for someone passionate about diagnostics innovation in a dynamic start-up setting.

What you’ll bring:

• Trial Planning and Execution: Lead the operational strategy for clinical trials, including site selection, patient recruitment, data collection, and monitoring. Coordinate with cross-functional teams (e.g., regulatory, biostatistics, and medical affairs) to ensure trials meet timelines, budgets, and quality standards.
• CRO and Vendor Management: Oversee relationships with Contract Research Organizations (CROs) and external vendors, including contract negotiation, performance monitoring, and issue resolution to optimize trial delivery.
• Team Leadership and Development: Provide line management to a team of clinical operations staff, including hiring, performance evaluations, mentoring, and professional development. Promote a collaborative culture that aligns with company goals.
• Regulatory Compliance: Ensure all trials adhere to Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other relevant standards. Manage risk assessments, protocol deviations, and audit preparations.
• Budget and Resource Management: Develop and track trial budgets, timelines, and resource allocations. Identify efficiencies to support scalable operations in a resource-constrained start-up environment.
• Stakeholder Communication: Serve as the primary point of contact for internal and external stakeholders, providing regular updates on trial progress, challenges, and milestones.
• Continuous Improvement: Analyze trial outcomes to refine processes, implement best practices, and contribute to the company's clinical operations playbook.

Qualifications and Requirements

• Education: Bachelor's degree in life sciences, nursing, or a related field.
• Experience: Minimum of 5 years in clinical trial operations, with demonstrated experience working with CROs in a US-based setting. Prior experience in diagnostics or medical device trials is highly desirable.
• Leadership: Proven track record in line management, with the ability to lead and motivate teams in a fast-paced environment.
• Technical Skills: Strong knowledge of clinical trial management systems (e.g., CTMS, eTMF), regulatory submissions, and data integrity practices.
• Soft Skills: Excellent communication, problem-solving, and organizational abilities. Ability to thrive in ambiguity and adapt to evolving priorities.
• Other: Willingness to travel up to 25% for site visits and meetings. Must be authorized to work in the US.

Preferred Qualifications

- Experience in start-up or small biotech environments.

- Certification in clinical research (e.g., CCRP or ACRP).

- Familiarity with diagnostic-specific regulations (e.g., CLIA, CAP).