Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality.
Ensuring inspection readiness by taking oversight over study eTMF completeness.
Driving continuous improvement initiatives within their remit of expertise.
Sharing best practices across business, focusing on increasing operational delivery efficiency.
Works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities.
Responsible for monitoring study conduct and progress, identifying, resolving, and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline, and budget objectives.
Reviewing key clinical documents, leading development of study plans, and managing study-specific deliverables.

At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
Knowledge of clinical trials, drug development process.
Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
Well familiar with key systems used in clinical trial delivery.
Experience in using Trial Master File industry accepted standard.
Strong project management skills (preferably with analytical / financial skills) and good leadership skills.
Excellent verbal and written communication in English.
Excellent communication and relationship building skills, including external service provider management skills.

Study Manager – FSP

Key skills