Mantell Associates are thrilled to have partnered with a leading CRO who partner with a huge variety of pharmaceutical and biotechnology sponsors across phases I through IV. They are looking for several additions to their US Statistics department, to support their client's clinical trial design and analysis, including a Senior Clinical Data Manager.

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Senior Clinical Data Manager - Responsibilities:

• Responsible for all Data Management tasks from study start-up to database lock for assigned studies

• Lead multiple large and complex studies, performing and delegating tasks as appropriate

• Effectively interact with sponsors and manage vendors

• Mentor junior personnel

• Develop SOPs and study-specific procedures

• Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures

• Work with programmers to design (e)CRFs and edit checks in EDC system for complex studies

• Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules

• Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming

• Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation

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Senior Clinical Data Manager - Requirements:

• Minimum BS in a scientific or health related field or equivalent

• Minimum 9 years of experience in Clinical Data Management

• Knowledge of medical terminology and pharmaceutical notation

• Expertise with EDC systems, such as Medidata Rave, InForm, Medrio

• Excellent organizational and time management skills

• Stong collaboration and leadership skills

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, please contact us at +1 (786) 495 1298.