Clinical Data Manager II/Senior Clinical Data Manager

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

📋 Description

• Responsible for overseeing all facets of the clinical trial data management process from study initiation through to post-database lock for assigned projects.

• Serve as the primary Data Management (DM) contact (Lead DM role) for designated clinical project(s) / program(s).

• Supervise the project data entry process, which includes the creation of data entry guidelines, training, ensuring data entry quality, and resource allocation.

• May conduct quality control checks on data entry.

• Provide input, evaluate, and manage project timelines.

• Execute User Acceptance Testing (UAT) for database builds and maintain documentation for quality-controlled database builds.

• Accountable for creating, updating, version controlling, and maintaining data management documentation.

• Educate clinical research staff on study-specific Case Report Forms (CRFs), Electronic Data Capture (EDC), and other project-related items as necessary.

• Review and query clinical trial data in line with the Data Management Plan.

• Conduct line listing data reviews following guidance from the sponsor and/or Lead DM.

• Generate reports on patient and study-level status and metrics.

• Execute medical coding of medical terms to ensure logical consistency and coherence.

• Coordinate the reconciliation of Serious Adverse Events (SAEs) and Adverse Events (AEs).

• Collaborate with third-party vendors.

• Identify and resolve operational challenges, issues, barriers, and obstacles for studies based on metrics data, audit reports, and feedback from project team members and other stakeholders.

• Contribute to the development and upkeep of Standard Operating Procedures (SOPs) and related process documentation.

⛳️ Requirements

• Bachelor's degree and/or a combination of relevant experience.

• Over 8 years of experience as a Senior Clinical Data Manager or at least 5 years as a Clinical Data Manager II in a Clinical Research Organization, Pharmaceutical, or Biotech firm.

• Experience in database setup and migrations.

• Oncology experience is preferred.

• Proficient in Microsoft Office applications: Word, Excel, PowerPoint, and Outlook.

• Exceptional organizational and communication abilities.

• Professional proficiency in the English language, both written and spoken.

• Experience with various clinical database management systems.

• Comprehensive knowledge of drug, device, and/or biologic development along with effective data management practices.

• Strong representation skills with the ability to communicate effectively in both oral and written forms.

• Excellent leadership and interpersonal skills.

• Willingness to undertake occasional travel.

🏝️ Benefits

• Opportunities for professional development.

• Flexible working hours.