Senior Clinical Data Manager (Remote - US)

About the role

MMS is an award-winning, data-focused clinical research organization (CRO) certified as a Great Place to Work, with an industry-best employee retention rate. We support pharmaceutical, biotech, and medical device companies with complex trial data and regulatory submissions across four continents.

Responsibilities

• Display excellent internal and external customer service
• Apply proficiency and knowledge of multiple EDC systems to advise customers on the best-fit EDC solution
• Interact directly and independently with DM suppliers (EDC and/or IWR); negotiate with suppliers to meet business needs
• Interact directly and independently with clients to coordinate all facets of projects; build and maintain strong client relationships
• Manage the entire data management process from study set-up to study close-out; serve as primary contact on all study-specific DM issues
• Actively participate in protocol review with clients, providing suggestions on capturing protocol information in the database
• Apply strong understanding of GCP/ICH guidelines and FDA regulations as applicable to data management
• Create training exercises; serve as mentor and train new clinical data managers
• Oversee and resolve all data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data), data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock, and database QC audits
• Oversee and develop data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan
• Prepare study tracking and metric reports for use by the study team
• Oversee execution of user acceptance testing (UAT) of study-specific systems and applications
• Interact with cross-functional team members to ensure completion of all timelines and studies
• Participate in data management and organizational initiatives
• Initiate SOP updates and provide specifications for DM systems/tools and process enhancements
• Act as resource for QC activities in collaboration with QC Coordinator
• Understand and follow processes related to project management for data management projects (e.g., updating PSS, close-out procedures)
• Maintain a confident, positive attitude towards clients and projects
• Demonstrate willingness to learn new skills and expand knowledge of drug development
• Lead data management projects with little management oversight
• Work independently and resolve issues
• Clearly articulate DM services offered, including pros and cons of various DM approaches; attend capabilities and bid defense meetings as needed

Requirements

• Bachelor's or Master's Degree in scientific or healthcare field preferred with industry or relevant experience
• 5+ years' experience in data management with a minimum of 1 year leading projects
• Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems
• Extensive knowledge of Clinical Operations SOPs and Working Practices
• Excellent verbal and written communication, interpersonal, and organizational skills