Clinical Data Reviewer, Sponsor-dedicated

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

📋 Description

• Conduct continuous clinical data evaluations to guarantee data quality, consistency, and completeness.

• Detect discrepancies and initiate/resolution queries within EDC systems.

• Examine patient data encompassing eligibility, medical history, treatment, safety data, and outcomes.

• Aid in the development and adherence to the Data Review Plan (DRP).

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

• Assist in data cleansing efforts prior to interim analyses and database locking.

• Work collaboratively with Clinical, Data Management, and Operations teams to address data-related issues.

• Oversee site data entry performance and report risks or delays as necessary.

• Engage in study meetings and offer status updates regarding data review processes.

• Ensure adherence to GCP, study protocols, and regulatory standards.

⛳️ Requirements

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

• Over 8 years of experience in clinical trials, with a strong emphasis on clinical data review.

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

• In-depth knowledge of clinical trial methodologies and GCP.

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

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

• Comparable experience, skills, and/or educational background will also be taken into account.

🏝️ Benefits

• Opportunities for career advancement and growth.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Reasonable accommodations, when appropriate, for employees or applicants with disabilities.