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Greg Wade
MedTech Divisional Manager at Mantell Associates
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Analyst, Management, and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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