Study Manager

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

📋 Description

• Collaborate across various internal and external partners to execute assigned operational tasks from initiation through to study archiving.

• Track study execution and advancement, proactively identifying, addressing, and escalating risks or issues as necessary.

• Assist Global Project Managers in overseeing Contract Research Organizations (CROs), monitoring study-specific deliverables, and ensuring timely execution of activities assigned to third parties.

• Supervise the activities of Project Specialists, ensuring that internal systems, databases, tracing tools, and project plans are fully complete.

• Organize and sustain interactions and meetings with both internal and external partners to guarantee the successful completion of designated studies.

• Manage vendor relationships effectively.

• Coordinate study-related tasks and oversee communication within the study team.

• Ensure the timely delivery of clinical supplies, investigational products, and all study-related materials.

• Oversee data to maintain inspection readiness of the study at all times, including ensuring the completeness of the electronic Trial Master File (eTMF).

• Manage budget tracking, including Task/Change Orders, expenses, tracking updates, ensuring consistency between systems and agreements, and escalating any issues to the Global Project Manager.

⛳️ Requirements

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

• Familiarity with clinical trials and the drug development process.

• In-depth understanding of ICH-GCP, the clinical study delivery process, including regulations, operational best practices, and industry standards.

• Experience utilizing Trial Master File industry-standard practices.

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

• Exceptional verbal and written communication skills in English.

• Demonstrated experience in clinical operations and/or study management is essential.

• Strong communication and relationship-building skills, including the ability to manage external service providers effectively.

🏝️ Benefits

• Various annual leave entitlements.

• A selection of health insurance options tailored to meet you and your family’s requirements.

• Competitive retirement planning options to enhance savings and confidently prepare for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting you and your family’s well-being.

• Life assurance.

• Flexible, country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.