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:

We are seeking an experienced Sr. CRA who has leadership experience to lead our clinical trial. The Sr. CRA is responsible for delivering high-quality clinical trial execution across assigned studies. This role combines advanced monitoring expertise with hands-on clinical trial management responsibilities, including vendor oversight, study planning, site management, and cross-functional coordination. The ideal candidate brings strong leadership, independent judgment, and the ability to proactively identify risks while ensuring compliance with ICH-GCP, regulatory requirements, and internal SOPs.

What you’ll bring:

· Occasionally, lead day-to-day operational management of assigned clinical studies from start-up through close-out.

· Develop, review, and maintain essential study documents (monitoring plans, manuals, trackers).

· Manage study timelines, deliverables, and milestones to ensure high-quality execution.

· Support budget development, contract review, and vendor selection as needed.

· Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance.

· Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues.

· Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues.

· Ensure site documentation meets regulatory and audit readiness standards.

· Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance.

· Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues

· Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues.

· Ensure site documentation meets regulatory and audit readiness standards.

Qualifications and Requirements:

Experience

· 5-8+ years of clinical research experience, including independent on-site and remote monitoring.

· Prior experience in a Sr. CRA or CTM role within a sponsor, biotech, or CRO environment.

· Demonstrated vendor oversight and project coordination experience.

· Prefer Experience within Oncology

· Bachelor’s degree in life sciences, nursing, pharmacy, or related field (or equivalent experience).

Skills & Competencies

· Strong knowledge of ICH-GCP and regulatory requirements.

· Excellent communication, presentation, and relationship-building skills.

· Ability to work independently, manage multiple priorities, and adapt to fast-paced environments.

· Strong analytical, problem-solving, and decision-making capabilities.

· Proficiency in CTMS, EDC, eTMF, and common clinical systems.