Senior Clinical Data Manager

Summary

Join Precision's Data Management team as a Senior Clinical Data Manager, working remotely from various European locations. You will manage all aspects of clinical trial data management, from study start-up to post-database lock. Responsibilities include overseeing data entry, database development, quality control, and training. You will collaborate with various stakeholders, vendors, and sponsors. This role requires extensive experience in clinical data management, specifically within oncology and/or orphan drug therapeutic areas. Strong leadership, communication, and technical skills are essential.

Requirements

• Possess a Bachelor's degree and/or a combination of related experience
• Have 8+ years’ experience with strong Oncology and/or Orphan Drug therapeutic experience
• Have experience in a clinical, scientific, or healthcare discipline
• Be proficient in Dictionary medical coding (MedDRA and WHODrug)
• Demonstrate an understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Have experience in utilizing various clinical database management systems
• Be proficient in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Possess broad knowledge of drug, device, and/or biologic development, effective data management practices, and the ability to handle a variety of clinical research tasks
• Possess excellent organizational, communication, and representational skills, with the ability to communicate effectively orally and in writing
• Be proficient in professional use of the English language; both written and oral
• Possess strong leadership and interpersonal skills
• Be able to undertake occasional travel

Responsibilities

• Serve as the Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s)/program(s), ensuring back-up, continuity, responsiveness, and timely task completion
• Oversee the project data entry process, including developing data entry guidelines, providing training, ensuring data entry quality, and managing resources
• Perform quality control of data entry
• Provide input, assess, and manage timelines; ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database
• Specify requirements for all edit check types (e.g., electronic, manual data review, edit checks, etc.). Oversee development of the edit check specifications and manual data review specifications
• Create, revise, appropriately version, and maintain data management documentation. Oversee 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 needed
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaise with third-party vendors (e.g., external data and EDC vendors) in a project manager capacity in support of timelines and data-related deliverables
• Assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• Review Request for Proposals (RFP), proposals, and provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Train and ensure that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, and present at project meetings
• Perform other duties as assigned

Preferred Qualifications

Experience with SAS programming