Manager, Centralized Data & Sample Management

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

📋 Description

• Take charge of planning and supervising clinical samples and external data sources for designated studies.

• Ensure the effective management of associated procedures and deliverables.

• Create the Sample Management Plan and establish data transfer agreements.

• Collaborate with third-party vendors regarding study documentation.

• Assist in the setup of vendor systems (e.g., labs, imaging).

• Keep the study team informed about data flows and reconciliation requirements.

• Conduct reconciliation between EDC and external data sources.

• Proactively identify transfer/data issues and trends, proposing solutions to address data and deliverables.

• Evaluate risks to timelines for data deliverables.

• Maintain proactive communication with the study team and external vendors concerning deliverables and status updates.

• Work closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory to ensure operational excellence.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in a scientific or healthcare-related field.

• A minimum of five years of experience in Clinical Data Management, sample management, third-party data sources, or Clinical Operations within the pharmaceutical or biotechnology sectors.

• Familiarity with third-party data/deliverables sources, including laboratory sample management.

• A comprehensive understanding of regulatory guidelines and industry standards associated with third-party data/deliverables.

• Strong project management skills with a proven ability to prioritize multiple tasks effectively.

• Attention to detail and the capability to work independently, as part of a multidisciplinary team, and with external partners and vendors.

• Experience collaborating with a globally distributed team.

• Knowledge of Risk-Based Monitoring principles and the use of critical thinking to evaluate and manage risks in assigned studies.

• Effective leadership abilities with a proven track record of enhancing team productivity and cohesion.

• Strong written and verbal communication skills in English.

• Proficient in computer systems and technical skills, with a strong aptitude for learning various computer applications.

🏝️ Benefits

• Health insurance.

• Annual performance-based bonus plan.

• Annual salary review.

• Total rewards incentives.