SRG, the leader in the Life Sciences human capital industry, is looking for a
full-time Manager of Clinical Data Management for a Global Pharmaceutical CRO located in Cambridge, Mass.
This role is responsible for managing and supervising a team of Clinical Data Managers (CDMs). Oversee each project assigned to the team.
Responsibilities include, but are not limited to:
Prepare and present individual performance reviews
Provide mentorship to DM staff and suggest/implement solutions for complex issues
Assist staff with interactions with sponsors and managing vendors
Keep supervisor updated on study progress and staff management through routine meetings
Develop and update data management SOPs and training manuals
Conduct data management training as well as study specific training for the CDM and study teams
Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
Oversee and participate in the process of data review and query generation procedures
Oversee/define/perform SAE reconciliation processes
Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system
Ensure proper completion of UAT of EDC system and modules
Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
WHAT YOU NEED TO HAVE:
Minimum BS in a scientific or health related field or equivalent
Minimum of 10 years of experience in Clinical Data Management
Minimum of 2 years supervisory experience is required
Skilled in the use of data management software application, Medidata RAVE
** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.
SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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