Clinical Trial Associate

Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T-cell engager programs, led by a potential first-in-class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease. Our lead asset is being developed for severe immune-mediated diseases, while additional preclinical programs expand the long-term potential of our R&D pipeline.

At Lakefront, we focus on advancing programs with strong biological rationale, clear clinical proof of concept and large commercial opportunities. We operate with small, empowered teams that work hands-on across development stages to move programs forward efficiently and thoughtfully. We are looking for people who want to contribute directly, who are motivated by solving real problems, collaborating across disciplines, and taking ownership from idea to impact. Every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients.

About the role

The Clinical Trial Associate (CTA) will support execution and oversight of multiple clinical studies as a key member of the Clinical Study Management Team, partnering with cross-functional colleagues, CROs, and lab vendors. This role will focus on study start-up, sponsor access management, vendor data reconciliation and QC, TMF oversight, and study tracking to ensure high-quality deliverables. The CTA will maintain oversight tools and documentation and contribute to process improvements.

Responsibilities

• Support clinical studies in partnership with CROs and lab vendors.
• Review and reconcile vendor data listings; perform QC checks to ensure accuracy and compliance.
• Monitor CRO/lab deliverables (sample data, reports, data transfers) against timelines and quality standards.
• Maintain study trackers, sponsor access management, oversight logs, and key documents (regulatory files, site/vendor contacts, approvals).
• Ensure completeness and compliance of the Trial Master File (TMF) through ongoing QC review.
• Assist with regulatory document review (EDPs, ICFs, lab certifications, IRB/IEC submissions).
• Support study start-up, site/vendor onboarding, and supply management.
• Contribute to study materials (manuals, newsletters, training content).
• Drive process improvement initiatives and strengthen vendor oversight practices.

Requirements

• Bachelor’s degree in life sciences, healthcare, or related field.
• 2+ years of experience as a CTA or in a similar role within a biotechnology, pharmaceutical, or CRO environment.
• Demonstrated experience supporting clinical study operations, including vendor oversight, data reconciliation, and QC review.
• Strong background in Trial Master File (TMF) maintenance and study documentation management.
• Proven ability to manage study progress/oversight tools.
• Excellent organizational, problem-solving, and communication skills with the ability to work effectively across cross-functional teams and with external partners.
• Skilled in Microsoft Office Suite (Excel, PowerPoint, Word) and comfortable with clinical trial tracking systems and tools.
• Highly detail-oriented, proactive, and able to manage multiple priorities independently.

Benefits

We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.

Pay

Base compensation for this position ranges from $110,000 - $130,000. Actual base compensation will be determined based on experience, qualifications, job-related knowledge, demonstrated skills, and geographic location. The company reserves the right to modify base salary ranges at any time. This position is also eligible for participation in Lakefront Biotherapeutics’ performance bonus plan.