Senior Clinical Trial Manager
We are looking for an experienced Senior Clinical Trial Manager to expand our Clinical Operations Team, reporting to the Compound Clinical Delivery Leader. The role will provide operational expertise, be responsible for the management of outsourced clinical trials and ensure successful operational planning, execution, close out and quality as per applicable regulations.
Key Responsibilities
- Lead global, complex Phase I-III clinical trials across multiple regions with full accountability for operational execution and delivery and act as primary point of contact for the assigned clinical studies;
- Provide operational leadership in trial design feasibility, operational planning, and risk mitigation.
- Drive CRO selection, contract negotiation, performance management, and oversight to ensure adherence to scope, quality, timelines, and budget.
- Proactively manage trial budgets, forecasting, and cost control, ensuring financial accuracy and efficiency.
- Oversee all operational aspects of the trial: site selection, study start-up, recruitment strategies, monitoring, data quality, and study close-out.
- Act as the primary point of contact for internal and external stakeholders.
- Contribute to the development, design and operational efficiency of clinical study documents, such as Clinical Study Protocols, Informed Consent Form, site guidelines, laboratory manuals, biomarker plan and other relevant clinical study documents
- Ensure compliance with ICH-GCP, global regulatory requirements, and company SOPs, aiming to be inspection-ready at all time.
- Mentor and provide leadership to junior clinical team members, fostering a high-performance team environment.
Skills, Knowledge and Expertise
- You have a master’s degree in the scientific, medical or paramedical area;
- You have ideally 8+ years of experience in clinical operations at a biotech or pharmaceutical company. Experience in early development projects and fibrotic indications is considered a plus;
- You have in-depth knowledge of ICH-GCP, clinical trial designs and clinical operations;
- You have a sound experience using Microsoft applications (Excel, Word, PowerPoint, Outlook);
- You are an excellent team player with strong oral and written communications skills;
- Your project management skills allow you to identify and adapt to shifting priorities and competing demands while having the ability to maintain composure in difficult circumstances;
- You speak and write English fluently. Additional languages are a plus;
- You are most of all a motivated, problem-solving, self-driven person, independently managing your time and projects.
Benefits
- The opportunity to develop pioneering science in a young biotech company;
- Challenging and innovative work environment as part of a driven team;
- Flexibility and responsibility based in Antwerp with remote working options that can be tailored for you;
- Competitive salary and benefits;
- An agile and fast paced environment.
About Agomab
Agomab is a young and dynamic biotech company developing medicine for patients with inflammatory and fibrotic diseases, including Crohn’s disease.
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