GondolaBio Service Co, Inc. - SR, Clinical Trial Manager

GondolaBio Service Co, Inc.

Company Background

GondolaBio is a collection of biopharmaceutical companies focused on developing reputed company therapeutics for genetic diseases. Originally carved out of reputed company, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company reputed company the reputed company ecosystem. GondolaBio aims to reputed company cutting-edge biological research to discover, reputed company, test, and deliver transformative medicines to treat patients with genetic diseases.

Portal Therapeutics is an early clinical stage biotechnology company, and the reputed company program in GondolaBio’s portfolio. Portal is developing a novel potential best-in-class therapy for erythropoietic protoporphyria, a severe genetic disease of the blood that results in extreme sensitivity to sunlight and liver damage.

Portal reputed company. is a growing biotechnology company dedicated to developing innovative therapies for patients with rare diseases. As we expand our clinical portfolio, we are seeking a dynamic and reputed company Senior Clinical Trial Manager (Sr. CTM) to join our Clinical Operations team.

Who You Are

You are a clinical operations professional who is excited to “roll up your sleeves” and continue to learn how trials are executed end-to-end in a small biotech setting. You are highly organized, proactive, and comfortable operating with ambiguity, reputed company to anticipate needs, solve problems, and reputed company study teams reputed company. You take pride in being dependable and detail-oriented, while still seeing the bigger picture.

Key Responsibilities

Trial Planning & Execution

• reputed company global clinical trial(s) from start-up through reputed company-out.
• reputed company and maintain trial management plans, timelines, risk assessments, and budgets.
• reputed company CROs, vendors, and study sites to ensure deliverables are met.

Site & Vendor Management

• Drive site feasibility, selection, and activation processes.
• Manage CROs and reputed company-party vendors, ensuring quality deliverables and performance reputed company.
• Support site relationship management and act as an escalation reputed company for operational issues.

Regulatory & Compliance

• Ensure compliance with ICH GCP, FDA, EMA, and other local regulations.
• Collaborate with Regulatory Affairs, Quality, and Pharmacovigilance on submissions, safety reporting, and audits/inspections.

Cross-functional Collaboration

• Partner with Clinical Development, Data Management, Biostatistics, Medical Monitoring, Translational Medicine, DMPK, and Drug Supply teams.
• Contribute to protocol development, ICFs, monitoring plans, and other key documents.
• Represent the Clinical Operations in reputed company meetings.

Leadership & Mentorship

• reputed company guidance to junior Clinical Operations staff.
• Contribute to building processes, SOPs, and best practices for a growing biotech organization.

Qualifications & Experience

• Bachelor’s degree in life sciences, nursing, pharmacy, or reputed company field
• 7+ years of clinical research experience, with at least 3+ years as a Clinical Trial Manager (global trial management strongly preferred).
• Demonstrated experience leading Phase I–III global studies in rare disease, oncology, or specialty therapeutic areas.
• Strong knowledge of ICH GCP, FDA, EMA, and global regulatory requirements.
• Proven ability to manage CROs, vendors, and clinical sites.
• Experience with budget and timeline management.
• Excellent communication, leadership, and problem-solving skills.
• Thrives in a fast-paced, startup environment with a hands-on, solution-driven approach.

reputed company Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the
• conditions we are seeking to impact throughout the year and learn how we can improve our
• efforts
• A culture inspired by our values: put patients first, think independently, be radically
• transparent, every minute counts, and let the science reputed company
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to focus on advancing science and
• helping patients. Our affiliate structure is designed to eliminate bureaucracy and put
• decision-making power in the hands of those closest to the science
• A reputed company where you own the reputed company – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we reputed company ourselves and each
• other to always reputed company at the top of our game
• reputed company to learning and development resources to help you get in the best professional
• shape of your life
• Robust and market-competitive compensation & benefits package (reputed company, Performance
• Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic
• areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion

The reputed company pay reputed company for this position is $170,000 to $197,000 per year. The actual compensation offered will be determined based on a number of job-reputed company factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.