Senior Clinical Data Manager - CRO

Mantell Associates is partnered with a highly regarded, full-service CRO in their search for a Senior Clinical Data Manager to join their team. Are you an experienced Clinical Data Manager with a passion for improving lives through clinical research? This is your chance to be part of an organization dedicated to delivering innovative healthcare solutions globally.

Senior Clinical Data Manager - Responsibilities:

• Data Management Leadership: Oversee all Data Management tasks for assigned studies from initiation to database lock. Lead and manage multiple large, complex studies, delegating tasks appropriately and ensuring team efficiency
• Documentation Development: Create and maintain study-specific documentation such as Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, and procedures for database audit and lock
• CRF and Edit Checks: Collaborate with database programmers to design eCRFs and implement edit checks in EDC systems for complex studies
• User Acceptance Testing (UAT): Lead, coordinate, and execute UAT for complex studies, ensuring thorough QC of EDC tools and modules, including database testing, data export testing, and custom programming verification
• Vendor Coordination: Work closely with sponsors and vendors to ensure seamless electronic data receipt, integration, and reconciliation
• Technical Troubleshooting: Address and resolve technical issues as they arise
• Data Review Processes: Develop effective processes for data review, query resolution, and management of data integrity
• Coding and Reconciliation: Perform coding of adverse events, medical conditions, and medications, as well as SAE reconciliation
• Database Management: Lead and execute pre-lock and data lock tasks, ensuring meticulous documentation and database archiving
• Training and Documentation: Prepare and deliver training materials and user guides for EDC data collection tools, and provide training to users
• Reporting and Metrics: Design and review status metric reports, identify trends, and communicate findings to stakeholders
• Project Coordination: Provide input on study timelines and resource needs, ensuring timely completion of project milestones. Keep cross-functional teams and sponsors informed of any changes
• Team Leadership: Provide mentorship to junior team members, delegate tasks effectively, and ensure their successful completion
• Client and Vendor Interaction: Engage with sponsors and manage vendor relationships for complex studies, ensuring high-quality deliverables
• Scope Management: Assist in identifying and managing project scope changes
• Sales Support: Represent the data management function in sales and marketing meetings with prospective clients
• SOP Development: Contribute to the development and updating of standard operating procedures and manuals

Senior Clinical Data Manager - Requirements:

• Minimum of a BS in a scientific or health-related field, or equivalent experience
• At least 9 years of experience in Clinical Data Management, preferably in a CRO setting
• Extensive knowledge of medical terminology and pharmaceutical notation
• Expertise with EDC systems such as Medidata Rave, InForm, and Medrio
• Outstanding organizational and time management skills
• Strong collaboration and leadership abilities
• Excellent communication skills for interacting with sponsors and team members

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.