This is a fully remote position, open to applicants in Poland, +2 more countries.

📋 Description

• Conduct continuous clinical data assessments to guarantee data quality, consistency, and thoroughness

• Detect discrepancies and initiate/resolve inquiries within EDC systems

• Examine patient information such as eligibility, medical history, treatment details, safety data, and outcomes

• Contribute to and adhere to the Data Review Plan (DRP)

• Validate data across various sources, including EDC, laboratories, and safety databases

• Assist in data cleansing tasks in preparation for interim analyses and database closure

• Collaborate with Clinical, Data Management, and Operations teams to address data issues

• Monitor the performance of site data entry and escalate any risks or delays

• Engage in study meetings and provide updates on data review progress

• Ensure adherence to GCP, protocols, and regulatory standards

⛳️ Requirements

• Scientific background (e.g., MSc, PhD, MD, PharmD, Nursing)

• Over 8 years of experience in clinical trials, demonstrating strong expertise in clinical data review

• Familiarity with EDC systems, data review tools, and query management

• In-depth understanding of clinical trial processes and GCP

• Experience with coding dictionaries (e.g., MedDRA) is advantageous

• Exceptional attention to detail, communication, and collaboration skills with stakeholders

• Equivalent experience, skills, and/or education will also be taken into account

🏝️ Benefits

• Opportunities for career development and advancement

• Supportive and engaged management

• Training in technical and therapeutic areas

• Recognition among peers

• Comprehensive total rewards program

• Emphasis on an inclusive culture

• Reasonable accommodations provided when appropriate