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

• Contributing to the successful execution of clinical studies within established timelines, budget, and quality standards.

• Ensuring readiness for inspections by managing the completeness of the study electronic Trial Master File (eTMF).

• Collaborating closely with the Study Delivery Lead on the operational aspects of study delivery.

• Monitoring the conduct and progress of studies, proactively identifying and addressing risks and issues.

• Reviewing critical clinical documents and leading the formulation of study plans.

• Facilitating interactions and meetings with both internal and external stakeholders.

• Overseeing vendor management and providing oversight of Contract Research Organizations (CROs).

• A university degree or equivalent, ideally in the medical or biological sciences.

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

• A solid understanding of clinical trials and the drug development process.

• Comprehensive knowledge of ICH-GCP guidelines and the clinical study delivery process.

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

• Strong project management and leadership capabilities.

• Exceptional verbal and written communication skills in English.

• Experience with the industry-standard Trial Master File.

• Health insurance

• 401(k) matching

• Flexible work arrangements

• Professional development opportunities

• Wellness programs

Study Manager

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