Clinical Operations Lead

Clinical Operations Lead

ProQR Therapeutics

Leiden, Netherlands

About the role:

The Development Department advances drug candidates from early research into clinical testing, ensuring they are thoroughly evaluated for safety and efficacy. Translational Development generates the data needed to move programs into the clinic, while Clinical Development designs and executes trials to demonstrate safety and efficacy in patients. Together, they connect science, medicine, and regulatory strategy to drive successful therapeutic development.

As a Clinical Operations Lead, you will serve as the operational leader of the clinical trial team and play a pivotal role in the successful execution of clinical studies. You are responsible for the end-to-end management of outsourced clinical trials and act as the primary point of contact between the organization and external service providers. In this role, you ensure that assigned clinical trials are delivered in line with agreed timelines, budgets, and operational and quality standards, while fully complying with applicable laws and regulations. You proactively identify, assess, and mitigate operational risks throughout the entire clinical trial lifecycle. You will provide hands-on oversight to safeguard data integrity and patient safety, including activities. Additionally, you are responsible for the set-up, ongoing maintenance, and overall quality of the Trial Master File for assigned studies.

We expect our Clinical Operations Lead to have:

• Minimum Bachelor’s degree in a life science-related field; an advanced degree in a health-related field is preferred;
• Minimum 5 years of experience as Clinical Operations Lead in management of global clinical trials, with a proven track record of managing outsourced clinical trials and CRO oversight;
• Excellent knowledge of the ICH-GCP guidelines and the relevant EMA/FDA regulations and the clinical development process.

Additional requirements:

• Experience in Phase 1-2 clinical trial management;
• Experience in selecting and managing External Service Providers (ESP), including qualification, set-up, project management oversight, performance assessments and finance management;
• Previous experience working with EDC, eTMF, CTMS systems; knowledge of some widely used eTMF/CTMS systems in multi-center, multi-national trial settings (e.g. Veeva Vault, Medrio, Medidata Rave, ClinSpark, etc.) is an advantage.

Skills and competencies that are required to make the difference:

• Hands-on mentality;
• Team player;
• Able to work in a fast-paced environment;
• Strong project planning and management skills;
• Able to prioritize multiple tasks;
• Critical thinking, decision-making, and problem-solving skills;
• Excellent communication skills;
• Proactive and pragmatic self-starter, with a result-oriented mindset.