PSI CRO

Pharmaceutical

DataManagerforClinicalTrials

€75–110k ~AI est. Sofia, Sofia City Province, Bulgaria FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for mid candidates.

The Brief

“Data Manager for Clinical Trials at PSI CRO. Skills: Clinical data management, Data validation. Track database set-up. Track database testing”

Industry & Context.

Pharmaceutical

What They're Looking For.

Must Have

College/University degree, Demonstrated experience managing clinical or medical data, Full working proficiency in English, Experience with Clinical Data Management systems, Proficiency in MS Office applications, Organisational and time management skills, Ability to work independently and multi-task

Nice to Have

Life Science degree, Pharmacy degree

What You'll Do.

Track database set-up

Track database testing

Track database maintenance

Communicate with clients on data management matters

Communicate with project teams on data management matters

Communicate with vendors on data management matters

Review study documents

Design project specific guidelines

Develop project specific instructions

Design Data Management Plans

Design Data Validation Plans

Ensure data follow-up

Ensure data validation

Perform manual CRF review

Perform SAE reconciliation

Track metrics leading to database lock

Report metrics leading to database lock

Coordinate processing of CRFs

Coordinate dispatch of CRFs

Coordinate archiving of CRFs

Coordinate processing of queries

Coordinate dispatch of queries

Coordinate archiving of queries

Maintain Clinical Data Management working files

Perform database QC checks

Train site staff on CRF completion

Train site staff on data management topics

Train project teams on CRF completion

Train project teams on data management topics

How You'll Work.

Team & Collaboration

Cross-functional teams

Full Job Description

PSI is a leading Contract Research Organization (CRO) with 30 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. 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. Please submit your CV in English 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, Pharm

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