Global Clinical Operations Lead - Trials & Compliance

ProQR Therapeutics; Leiden; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

8% holiday allowance

30 vacation days

Annual performance bonus

Stock options

Pension plan

Commuting allowance

Subsidized staff restaurant

Snacks and drinks

Employee events

Résumé du poste

ProQR Therapeutics in Leiden, NL is seeking a Clinical Operations Lead (full-time) to direct end-to-end management of outsourced clinical trials, ensuring data integrity and patient safety.

You will serve as the operational lead for the trial team, liaising with CROs, managing timelines and budgets, and upholding ICH-GCP and EMA/FDA regulations.

The role requires a Life Science bachelor’s degree, at least 5 years in global trial leadership, and strong project management and communication skills.

Qualifications

• Minimum Bachelor’s degree in a life science-related field.
• Minimum 5 years of experience as Clinical Operations Lead in global trials.
• Excellent knowledge of ICH-GCP guidelines and EMA/FDA regulations and the clinical development process.
• Experience in selecting and managing External Service Providers (ESP) including qualification, setup, project management oversight, and finance management.

Responsabilités

• Oversee end-to-end management of outsourced clinical trials.
• Serve as primary point of contact with external service providers.
• Ensure trials are delivered on time, on budget, and to quality standards.
• Maintain the Trial Master File setup and ongoing updates.

Connaissances

Hands-on mentality

Team player

Project planning

Prioritize tasks

Excellent communication

Proactive self-starter

Formation

Bachelor’s degree in life science

Advanced degree preferred

Outils

EDC

eTMF

CTMS

Veeva Vault

Medrio

Medidata Rave

ClinSpark

Description du poste

ProQR Therapeutics in Leiden, NL is seeking a Clinical Operations Lead (full-time) to direct end-to-end management of outsourced clinical trials, ensuring data integrity and patient safety.

You will serve as the operational lead for the trial team, liaising with CROs, managing timelines and budgets, and upholding ICH-GCP and EMA/FDA regulations.

The role requires a Life Science bachelor’s degree, at least 5 years in global trial leadership, and strong project management and communication skills.