Global CNS Trials Lead

Clinilabs; Basel; Hybrid; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Clinilabs is seeking a Global Project Manager to oversee cross-functional, multi-regional CNS clinical trials from protocol concept to final study report, ensuring timelines, budget and quality.

You will lead client communications, vendor management and risk mitigation, collaborate with regulatory, data management and medical science teams, and drive process improvements aligned with ICH-GCP, FDA/EMA standards. Travel may be required.

Qualifikationen

• Bachelor's degree plus approximately 5–7 years of direct clinical research project management experience.
• Proven track record managing complex, multi-region, global trials (2+ regions).
• Strong CNS therapeutic expertise with experience in CNS trials (Alzheimer's, Parkinson's, etc.).
• Solid understanding of CNS endpoints and strategies to mitigate placebo effects.
• Knowledge of drug development, initiation, monitoring, data management, statistics, safety, and regulatory issues.
• Proficiency with ICH/GCP guidelines, FDA/EMA regulations, CTMS/EDC/eTMF, and project management tools.

Aufgaben

• Develop and implement global project plans (IQMP, Risk Management) to ensure on-time, on-budget delivery.
• Ensure adequate site facilities and staff for global trials.
• Monitor protocol-related activities with Clinical Manager and align monitoring teams.
• Approve and implement SOPs, policies, and project governance.
• Lead sponsor communications and manage overall study conduct, timelines, quality, and budget.

Kenntnisse

Project management

CNS Therapeutic Expertise

Communication skills

Cross-functional coordination

Ausbildung

Bachelor's degree (Life Sciences/Pharmacy/Nursing or related); Master’s preferred

Tools

MS Project

CTMS

EDC

eTMF

Jobbeschreibung

Clinilabs is seeking a Global Project Manager to oversee cross-functional, multi-regional CNS clinical trials from protocol concept to final study report, ensuring timelines, budget and quality.

You will lead client communications, vendor management and risk mitigation, collaborate with regulatory, data management and medical science teams, and drive process improvements aligned with ICH-GCP, FDA/EMA standards. Travel may be required.