Clinical Data Manager II/Senior Clinical Data Manager

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

📋 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. May include DM oversight of sponsor programs.

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

• May carry out quality control for data entry.

• Provide insights, evaluate, and manage timelines. Ensure 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 coordinate the review and feedback from all relevant stakeholders.

• Conduct User Acceptance Testing (UAT) for the database build and maintain documentation that is quality controlled. Oversee the overall quality of the clinical database.

• May define requirements for all types of edit checks, such as electronic, manual data review, and edit checks. Oversee the development of edit check specifications 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 the study-specific CRF, EDC, and other related project items as required.

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

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

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

• Perform medical coding of medical terms in relation to each other to ensure medical logic and consistency.

• Coordinate Serious Adverse Event (SAE) and Adverse Event (AE) reconciliation.

• Act as a liaison 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 address operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

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

• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and relevant process documentation related 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.

• Provide leadership for cross-functional and organization-wide initiatives, as applicable.

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

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

• May present software demonstrations and training sessions, as well as departmental or company training sessions and project meetings.

• 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 in a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience in setting up and migrating databases.

• Experience in oncology is preferred.

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

• Exceptional organizational and communication skills.

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

• Experience with various clinical database management systems.

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

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

• Strong leadership and interpersonal abilities.

• Willingness to undertake occasional travel.

🏝️ Benefits

• May require some travel.