Senior Clinical Research Associate / Associate Clinical Trial Manager

The Senior Clinical Research Associate / Associate Clinical Trial Manager will support the planning, execution, oversight, and delivery of clinical trials from study start-up through closeout. This sponsor-side role combines hands-on clinical monitoring and site management with growing responsibility for study-level operational leadership. You will coordinate activities across internal teams, CROs, vendors, investigators, and clinical sites to keep trials on schedule and aligned with quality and regulatory expectations. Working across multiple therapeutic programs and functions, you will help identify operational risks, maintain study readiness, and support high-quality clinical data and documentation. This is an opportunity to contribute directly to the development of innovative treatments for patients with genetic diseases in a collaborative, patient-focused, and fast-paced environment.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field, or equivalent relevant experience.

• At least 4 years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment, including CRA and clinical site monitoring experience.

• Experience supporting clinical trials through study start-up, conduct, and closeout; sponsor-side experience is preferred.

• Working knowledge of ICH-GCP, applicable clinical research regulations, and the clinical trial process.

• Experience working with clinical sites, CROs, and external study vendors.

• Familiarity with common clinical trial systems, including EDC, CTMS, eTMF, IRT, and eCOA.

• Strong organizational and project coordination skills, with the ability to manage multiple priorities and study deliverables.

• Excellent written and verbal communication skills and the ability to collaborate effectively with cross-functional and geographically distributed teams.

• Detail-oriented and proactive approach, with the ability to identify, assess, and escalate study issues appropriately.

• Ability to work independently in a remote environment and maintain effective communication with study teams, CROs, vendors, investigators, and clinical sites across multiple time zones.

• Availability to participate regularly in virtual study-team, CRO/vendor, and site meetings.

• Willingness to travel approximately 10–20% for sponsor oversight visits, investigator meetings, critical site visits, internal meetings, and other study-related activities.

Professional qualities:

• Patient-focused approach and commitment to high ethical standards.

• Ownership mindset, practical problem-solving ability, and sound judgment.

• Intellectual curiosity, attention to detail, and a commitment to excellence.

• Ability to work collaboratively and deliver against goals and milestones with quality, precision, and efficiency.