Clinical Data Manager II / Senior Clinical Data Manager

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

📋 Description

• Serve as the primary Data Management (DM) contact (Lead DM role) for designated clinical project(s) / program(s), ensuring backup, continuity, responsiveness, and timely task execution. May provide support to another Lead DM as a backup and/or team member, which may involve DM oversight of sponsor programs.

• Supervise the project data entry process, including the creation of data entry guidelines, training, quality control of data entry, and resource allocation.

• May conduct quality control checks on data entry.

• Provide input, assess, and manage project timelines, ensuring clinical data management deadlines are met with high quality. Evaluate resource requirements for assigned projects as necessary.

• May develop Case Report Form (CRF) specifications based on the clinical study protocol and coordinate feedback and reviews from all stakeholders.

• Perform User Acceptance Testing (UAT) for database builds and maintain documentation for quality-controlled database builds. Ensure the overall quality of the clinical database.

• May define requirements for all types of edit checks, such as electronic and manual data reviews, and oversee the development of edit check and manual data review specifications.

• Responsible for the creation, revision, appropriate versioning, and maintenance of data management documentation. Ensure completeness of data management documentation for the Trial Master File.

• Train clinical research personnel on study-specific CRF, Electronic Data Capture (EDC), and other project-related items as required.

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

• Conduct line listing data reviews based on guidelines provided by the sponsor and/or Lead DM.

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

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

• Coordinate the reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).

• Liaise with third-party vendors, such as external data and EDC vendors, in a project management capacity to support timelines and data-related deliverables.

• May assist with SAS programming and quality control of SAS programs utilized in the Data Management department.

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

• May contribute to the review and feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project.

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

• May attend strategy meetings, bid defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings.

• May review Requests for Proposals (RFP), proposals, and provide project estimates.

• Offer leadership for cross-functional and organization-wide initiatives, where appropriate.

• Train and ensure that all data management project team members receive adequate training.

• Communicate with study sponsors, vendors, and project teams regarding data, database, or other relevant project concerns as necessary.

• May deliver software demonstrations/trainings, conduct department/company training sessions, and present at project meetings.

• Some travel may be required.

• Perform additional duties as assigned.

⛳️ Requirements

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

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

• Experience with database setup and migrations.

• Oncology experience is preferred.

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

• Outstanding organizational and communication skills.

• Professional proficiency in English, both written and verbal.

• Experience with various clinical database management systems.

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

• Strong representational skills with the ability to communicate effectively both orally and in writing.

• Excellent leadership and interpersonal skills.

• Willingness to undertake occasional travel.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Opportunities for professional development.