Study Manager

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

📋 Description

• Collaborate closely with the Study Delivery Lead to assist in the comprehensive operational execution of clinical studies, spanning from initiation to closure and archiving.

• Develop, sustain, and supervise study plans, internal systems, databases, trackers, and project documentation to ensure effective study implementation.

• Work collaboratively across functions with internal teams and external partners, including CROs and vendors, to manage study operations throughout all phases and therapeutic areas, adhering to relevant regulations, operating models, and industry standards.

• Track study progress, proactively detect risks or issues, and escalate or address challenges that could affect quality, timelines, or budget.

• Review and contribute to essential clinical documents such as protocols, informed consent forms, and operational plans (e.g., Monitoring Plans, Risk Management Plans, Vendor Oversight Plans, Communication Plans).

• Lead and facilitate interactions with internal stakeholders (e.g., regulatory, quality, local country teams) and external vendors to ensure coordinated and effective study delivery.

• Provide oversight of CROs and third-party suppliers, serving as the main point of contact and ensuring the delivery of contracted services meets agreed timelines and quality standards.

• Manage country-level study activities, including recruitment progress, data quality, regulatory approvals, protocol deviations, and compliance tracking.

⛳️ Requirements

• A university degree (or equivalent), preferably in life sciences, medical sciences, or a related clinical research field.

• A minimum of 3+ years of experience within a pharmaceutical, biotech, or clinical research setting.

• Solid grasp of clinical trials and the drug development lifecycle.

• Comprehensive knowledge of ICH-GCP, regulatory requirements, and best practices in clinical study delivery.

• Experience with industry-standard clinical systems, including Trial Master File (TMF/eTMF).

• Proven project management skills, with strong organizational, analytical, and financial acumen.

• Exceptional written and verbal communication skills in English.

• Demonstrated ability to forge effective relationships and manage external service providers.

🏝️ Benefits

• Various annual leave entitlements.

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

• 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, among others.