Associate Data Manager

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Conduct quality control and consistency assessments on study data outputs, ensuring precision between source data, edit check outputs, and final deliverables.

• Examine data inconsistencies and work alongside Data Managers, scientific teams, and medical personnel to facilitate the resolution of issues and documentation.

• Aid in the development, upkeep, and review of study documentation, including Data Management Plans, Data Transfer Specifications, and associated deliverables.

• Manage updates to Clinical Data Management task timelines, encompassing edit checks, transfer schedules, reconciliation efforts, and final data transfer specifications.

• Assist with data management metrics, monitor study tracking activities, and ensure accurate study assignment information is maintained within relevant systems.

• Support the preparation, formatting, and upkeep of data management documents, templates, reports, and presentations.

• Act as the primary contact for client reconciliation feedback, ensuring prompt investigation, follow-up, and resolution of data-related inquiries.

• Uphold high-quality documentation and audit-ready records concerning reconciliation activities and study data management procedures.

• Effectively communicate project status updates to internal teams, project leaders, and clients.

• Assist in organizing, storing, and maintaining study documentation throughout the project's lifecycle.

• Contribute to continuous improvement efforts focused on optimizing workflows, enhancing quality, and improving process efficiency.

• Support Corrective and Preventive Action initiatives related to study-specific data management processes.

⛳️ Requirements

• Bachelor’s, Master’s, or PhD degree in Life Sciences, Healthcare, Pharmaceutical Sciences, Clinical Research, Data Science, or a related field, or equivalent practical experience.

• Preferred experience in the pharmaceutical, biotechnology, healthcare, life sciences, or clinical research sectors.

• Basic understanding of Clinical Data Management principles and the function of data management in clinical trials.

• Ability to review, interpret, and comprehend clinical trial protocols, study documentation, and sponsor requirements.

• Preferred knowledge of Good Clinical Practice, FDA, EMA, and other relevant regulatory standards.

• Highly desirable exposure to eClinical technologies such as eCOA, ePRO, eConsent, RTSM/IRT, or similar clinical systems.

• Previous experience in clinical research roles, including Clinical Research Associate, Study Coordinator, Project Assistant, Project Coordinator, Clinical Trial Assistant, or similar positions preferred.

• Familiarity with SAS, SQL, or other data analysis and reporting tools is highly desirable.

• Knowledge of CDISC standards, including SDTM, is considered an asset.

• Strong analytical, organizational, and problem-solving abilities with exceptional attention to detail.

• Excellent written and verbal communication skills with the capability to work effectively within cross-functional global teams.

• Capacity to manage multiple priorities and deliver high-quality work in a deadline-driven environment.

🏝️ Benefits

• Competitive compensation and incentives

• Private medical coverage and MetLife protection

• SZÉP Card and telework reimbursement

• Flexible time off

• Engaging employee events

• Hybrid technology support