Senior Clinical Data Manager

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

📋 Description

• Accountable for managing all facets of the clinical trial data management process from the initiation of the study to post-database lock for designated projects.

• Serves as the primary Data Management (DM) contact (Lead DM role) for assigned clinical projects/programs.

• Supervise the project data entry process, which includes the development of data entry guidelines, training, quality assurance for data entry, and resource allocation.

• May conduct quality control for data entry activities.

• Provide input, evaluate, and manage project timelines.

• May create CRF specifications based on the clinical study protocol.

• Execute database build UAT and uphold quality-controlled documentation of database builds.

• Tasked with creating, updating, versioning, and preserving data management documentation.

• Instruct clinical research staff on the study-specific CRF, EDC, and other relevant project components as necessary.

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

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

• Generate patient and study-level status and metric reports.

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

• Coordinate the reconciliation of SAE/AE.

• Collaborate with third-party vendors, including external data and EDC providers.

• Identify and resolve operational challenges, issues, and barriers affecting studies.

• Contribute to the creation and maintenance of Standard Operating Procedures (SOPs) and related process documentation for data management and database management activities.

• Engage in communication with study sponsors, vendors, and project teams regarding data, database, or other pertinent project matters.

⛳️ Requirements

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

• Over 8 years of experience as a Senior Clinical Data Manager or more than 5 years as a Clinical Data Manager II within a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience in database setup and migrations.

• Preferred experience in oncology.

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

• Exceptional organizational and communication abilities.

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

• Familiarity with various clinical database management systems.

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

• Strong representational abilities, with effective oral and written communication skills.

• Strong leadership and interpersonal skills.

• Willingness to undertake occasional travel.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.