Clinical Trial Manager

Lakefront Biotherapeutics NV; Mechelen; Hybride; EUR 129 000 - 141 000; Plein temps

Avantages offerts par ce poste

Benefits package

Résumé du poste

Lakefront Biotherapeutics is seeking a Clinical Trial Manager to lead the operational aspects of selected clinical studies from study start-up through the clinical study report. You will evaluate timelines and budgets, select CROs, oversee vendors, site selection, and contribute input on clinical processes and guidelines.

The role requires strong organizational and communication skills, experience leading Phase I-III trials, and ability to work in a matrix environment.

Qualifications

• BS/BA in the life sciences or a related field.
• 5-7 years of experience in clinical operations in biotech or pharma; autoimmune or rare disease experience desired.
• Direct study management experience at the global level preferred.
• Proficiency in Excel; creating metrics and dashboards for internal stakeholders.
• Experience with clinical systems (EDC, IRT, TMF, CTMS).

Responsabilités

• Lead clinical study execution and oversee all operational aspects.
• Organize and run study team meetings to ensure clear communication and risk mitigation.
• Identify and select CROs and third-party vendors; oversee their performance.
• Ensure vendor training on study documents for team members.
• Develop clinical protocols, amendments, consent forms, study plans, and related documents with cross-functional teams.
• Maintain relationships with investigators and study staff.
• Ensure compliance with protocol, SOPs, ICH/GCP, and manuals.
• Participate in feasibility for new sites; review CRFs and databases for integration.
• Collaborate with Data Management to ensure data quality and timely cleaning.
• Manage study budgets and vendor invoices; approve changes with partners.
• Provide guidance to internal and external partners; perform other duties as assigned.

Connaissances

Strong organizational skills

Written and verbal communication

Self-starter

Willingness to travel up to 10%

Formation

BS/BA in life sciences

Outils

Excel

EDC

IRT

TMF

CTMS

Description du poste

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.

Are you ready to transform lives and be part of a journey like no other? We are building a company where science, execution, and accountability matter. Rather than layers of hierarchy, 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. At Lakefront, every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients.

If you are driven to improve the lives of patients, energized by execution, and excited to help build a growing company with a strong balance sheet, we look forward to meeting you.

The Role

Reporting to the Vice President of Clinical Operations, Lakefront Biotherapeutics is hiring a Clinical Trial Manager to manage the operational aspects of specific clinical studies from study start‑up through clinical study report. This includes evaluation of clinical trial timelines, budgets, quality of deliverables, clinical vendor selection and oversight of activities, site selection and site management and provision of input into clinical processes, procedures, and guidelines. The CTM drives completion of all study deliverables, ensuring the highest quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required.

What You’ll Do

• Responsible for clinical study execution and oversight of all operational aspects.
• Organize and run study team meetings regularly to ensure clear and current communication, escalation of potential issues to the appropriate functional leads, and team‑based problem solving and risk mitigation of any arising roadblocks.
• Contribute to the identification and selection of appropriate CROs and third‑party study vendors.
• Oversee the performance of CROs and vendors to ensure the execution of the study.
• Ensure the study team members’ vendor training on the study documents.
• Manage the development of clinical protocols, amendments, informed consent forms, study plans, and any other clinical research related documents, in collaboration with cross‑functional team members or CRO partners.
• Establish and maintain excellent working relationships with investigators and study staff.
• Ensure studies are carried out according to the study protocol, SOPs, ICH/GCP guidelines, and study‑specific manuals and procedures.
• Participate in the feasibility process for finding and selecting new study sites.
• Review and comment on CRFs and database build to ensure integration of all critical aspects of the clinical study being reflected in the clinical database.
• Review key study quality metrics (e.g., eligibility primary endpoint data,), and determine appropriate action in conjunction with the study team.
• Collaborate with Data Management to oversee data quality issues and timely execution of data cleaning efforts to ensure timely data entry and continuous data quality improvements.
• Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review and updates or revisions with cross‑functional partners as necessary.
• Provide study‑related guidance and leadership to internal and external partners, as appropriate.
• Other duties as assigned.

What You Bring

• BS/BA in the life sciences or a related field.
• 5-7 years of experience in clinical operations in the biotechnology or pharmaceutical industry; experience in autoimmune or rare disease experience highly desirable.
• Direct study management experience at the global level preferred.
• Demonstrated proficiency in Excel, creating metrics and dashboards for internal stakeholders.
• Experience with clinical systems including various EDC, IRT, TMF, CTMS, etc.
• Strong organizational, written and verbal communication skills.
• Willingness to travel up to 10% of the time.
• A self‑starter who can take on building the operational backbone for early phase clinical studies.
• Experienced in leading Phase I-III clinical trials.
• Participation in large multi‑center and/or global trials, investigational site and CRO management, data collection, study protocol compliance.
• Solid understanding of US and global regulations and guidelines (FDA, EMA, ICH).
• Experience in working in a highly matrix environment and ability to execute in the context of internal and external (vendor) cross‑functional teams.
• Desire to learn and grow in scientific knowledge, managerial capabilities, and personal development.
• Willingness to take a hands‑on approach.

Base compensation for this position ranges from $150,000 -165,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job‑related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics’ performance bonus plan.

Benefits and Perks

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

At Lakefront Biotherapeutics, we are committed to attracting individuals who bring strong expertise, integrity, and a collaborative mindset. We value people who take ownership, work effectively across teams, and want to contribute to meaningful progress.

You will join a highly motivated and supportive team working together to advance our pipeline and strengthen how we operate. As we continue to build and grow, we offer an environment where individuals can develop, take on responsibility, and make a tangible impact.

Lakefront Biotherapeutics is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.