Clinical Data Manager

Company Description

PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

Job Description

We are currently growing in Bulgaria and looking for a Clinical Data Manager to join our global team.

Clincial Data Manager plays a critical role in the clinical research project. If you are detail-oriented and committed to quality, able to work with large volume of clinical or medical data, you might be the professional we are looking for.

Responsibilities will include:

• Track database set-up, testing, maintenance and data entry
• Communicate with clients, project teams and vendors on data management matters
• Review study documents, design and develop project specific guidelines and instructions
• Design eCRF, Data Management and Data Validation Plans and test EDC databases
• Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
• Code medical data
• Track and report metrics leading to database lock
• Coordinate the processing, dispatch and archiving of CRFs/queries
• Maintain Clinical Data Management working files
• Perform database QC checks, prepare and attend audits
• Train site staff and project teams on CRF completion and data management topics

Qualifications

• College/University degree (Life Science, Pharmacy degree is a plus)
• Prior experience with clinical or medical data
• Full working proficiency in English
• Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm) is desirable
• Proficiency in MS Office applications
• Organisational and time management skills
• Ability to work independently and multi-task

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. 

Please submit your CV in English