Clinical Data Manager II/Senior Clinical Data Manager

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

📋 Description

• The Clinical Data Manager II/Senior Clinical Data Manager is tasked with overseeing all facets of the clinical trial data management process, from the initiation of the study to post-database lock for designated projects.

• Acts as the primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring backup, continuity, responsiveness, and timely task execution.

• Supervise the project data entry process, which includes developing data entry guidelines, training, ensuring data entry quality, and managing resources.

• May conduct quality control checks on data entry.

• Provide insights, evaluate, and manage timelines, ensuring clinical data management deadlines are met with high quality.

• Assess resource requirements for assigned projects as necessary.

• May create CRF specifications based on the clinical study protocol and facilitate the review/feedback process from relevant stakeholders.

• Conduct user acceptance testing (UAT) for database builds and maintain documentation that confirms quality-controlled database builds.

• Ensure the overall quality of the clinical database is maintained.

• May delineate requirements for all types of edit checks, including electronic checks, manual data reviews, and more.

• Supervise the development of edit check specifications and manual data review guidelines.

• Responsible for generating, updating, versioning, and maintaining data management documentation.

• Ensure completeness of data management documentation for the Trial Master File.

• Train clinical research personnel on study-specific CRF, 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 sponsor and/or Lead DM guidance.

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

• Perform medical coding of medical terms to ensure logical and consistent medical connections.

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

• Collaborate with third-party vendors such as external data and EDC vendors in a project manager role to support timelines and deliverables related to data.

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

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

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

• Engage in the development and upkeep of Standard Operating Procedures (SOPs) and related process documentation concerning data management and database management activities.

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

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

• Offer leadership for cross-functional and organization-wide initiatives when applicable.

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

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

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

• Perform additional duties as assigned.

⛳️ 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, specifically within a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience in database setup and migrations.

• Oncology experience is preferred.

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

• Outstanding organizational and communication abilities.

• Professional command of the English language, both written and spoken.

• Experience with various clinical database management systems.

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

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

• Exceptional leadership and interpersonal skills.

• Willingness to undertake occasional travel.

🏝️ Benefits

• May require some travel.