About
ClinSoft LLC, a subsidiary of the U.S.-based ClinStatDevice, is a clinical research technology and data analytics company based in Yerevan, Armenia. We support international clinical research projects across data management, biostatistics, statistical programming, and analytics, collaborating with leading pharmaceutical and healthcare companies in the U.S. and Europe.
We are looking for an experienced Data Manager to ensure the quality, accuracy, and integrity of clinical trial data throughout the study lifecycle. The role involves clinical data management activities, EDC systems, data validation, and close collaboration with cross-functional project teams.
Responsibilities
•Participate in the preparation and review of clinical research documentation, including Protocols, CRFs, DMPs, and DVPs.
•Support database setup and programming activities in collaboration with statistical programmers and biometrics teams.
•Contribute to CRF/eCRF design, SDTM annotation, and completion guidelines.
•Perform UAT, edit check testing, data entry testing, and raw data review.
•Provide EDC and process training to CRAs and clinical site personnel.
•Conduct manual data reviews, discrepancy management, and query resolution.
•Perform CRF and external data reconciliation, including laboratory, ECG, and imaging data.
•Ensure clinical data quality and completeness before database lock/freeze.
•Monitor project progress, prepare status reports, and participate in project and client meetings.
•Ensure compliance with company procedures and QMS, ISMS, and PIMS requirements.
Requirements
•University degree in Data Science, Data Management, Computer Science, Economics, or a related field.
•3-5 years of experience in Data Management.
•Strong knowledge of pharmaceutical development, clinical research, clinical data management, and clinical information systems.
•Understanding of regulatory requirements, including US FDA and EMA processes.
•Strong organizational and project management abilities.
•Excellent interpersonal and communication skills.
•Ability to work independently and collaboratively within cross-functional teams.
•Strong attention to detail, analytical thinking, and problem-solving skills.
•Ability to understand directions, take ownership of assigned tasks, and communicate progress or challenges in a timely manner.
Nice to have
•PhD preferred
•GCP certification is preferred
Conditions
No conditions specified in the posting.
