SRG, the leader in the Life Sciences human capital industry, is looking for a Clinical Data Manager for a Global Pharmaceutical CRO located in Cambridge, Mass. This role is responsible for developing and maintaining 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. This position is located on site.

Responsibilities include, but are not limited to:

• Work with DB 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
• Perform coding of adverse events, medical conditions and medications.
• Perform SAE reconciliation
• Lead and perform pre-lock and data lock tasks
• Prepare training materials and user guides for EDC data collection tools, deliver user training
• Provide study specific training for team members and end users, as appropriate
• Lead client and team meetings as required
• Interact with sponsors and manage vendors for complex studies
• Develop SOPs and manuals

WHAT YOU NEED TO HAVE:

• Minimum 8 years of experience in Clinical Data Management
• Minimum BS in a scientific or health related field or equivalent
• Previous experience working for a CRO preferred
• Knowledge of medical terminology and pharmaceutical notation
• Expertise with EDC systems, such as Medidata Rave, InForm, Medrio

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.