Data Manager (Clinical Trials)

TL;DR

Data Manager (Clinical Trials): Managing clinical trial databases and ensuring data quality for pharmaceutical projects with an accent on eCRF design, data validation, and medical coding. Focus on coordinating with clients and vendors, performing database QC checks, and ensuring readiness for database lock.

Location: Sofia, Bulgaria

Company

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry, supporting clinical trials globally.

What you will do

• Track database set-up, testing, maintenance, and data entry processes.
• Design eCRF, Data Management, and Data Validation Plans, including EDC database testing.
• Communicate with clients, project teams, and vendors on all data management matters.
• Ensure data entry, follow-up, and validation, including SAE reconciliation and medical data coding.
• Perform database QC checks and prepare for audits to achieve database lock.
• Train site staff and project teams on CRF completion and data management topics.

Requirements

• University degree in Life Science (Pharmacy degree is a plus).
• Demonstrated experience in managing clinical or medical data.
• English: Full working proficiency required.
• Experience with Clinical Data Management systems such as Medidata Rave or Oracle InForm.
• Proficiency in MS Office applications.
• Strong organizational, time management, and multi-tasking skills.

Culture & Benefits

• Opportunity to work in a growing company with a strong focus on people.
• Inclusive culture that values diversity and global talent.
• Environment supporting groundbreaking advancements in the pharmaceutical industry.