Study Manager – FSP

This is a fully remote position, open to applicants in Serbia.

📋 Description

• The Study Manager (SM) plays a vital role within the Global Study Team, ensuring the clinical study is delivered on time, within budget, and to the required quality standards.

• Responsible for maintaining inspection readiness by overseeing the completeness of the study eTMF.

• Leading initiatives aimed at continuous improvement within their area of expertise.

• Sharing best practices across the organization with an emphasis on enhancing operational delivery efficiency.

• Collaborating closely with the Study Delivery Lead (SDL) on comprehensive operational study delivery tasks.

• Accountable for monitoring the progress and conduct of the study, identifying, addressing, and escalating risks or issues that may affect the study's quality, timeline, and budget goals.

• Reviewing essential clinical documents, spearheading the development of study plans, and overseeing study-specific deliverables.

⛳️ Requirements

• A minimum of 3+ years of relevant experience in a pharmaceutical or scientific setting.

• Understanding of clinical trials and the drug development process.

• Comprehensive knowledge of ICH-GCP, the clinical study delivery process, including applicable regulations, operational best practices, and industry standards.

• Familiarity with key systems utilized in the delivery of clinical trials.

• Experience with Trial Master File industry standards.

• Strong project management capabilities (preferably with analytical and financial skills) along with effective leadership qualities.

• Exceptional verbal and written communication skills in English.

• Outstanding communication and relationship-building abilities, including skills in managing external service providers.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off