Senior Clinical Data Manager (Remote - US)

MMS is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. As a Great Place to Work certified organization, we are recognized for our exceptional culture and industry-best employee retention rate. With a global footprint across four continents, MMS fosters a collaborative and inclusive work environment where employees can thrive.

Responsibilities

• Display excellent internal and external customer service
• Demonstrate proficiency and knowledge of multiple EDC systems; advise customers on the best-fit EDC solution
• Interact directly and independently with data management (DM) suppliers, including EDC and/or IWR; negotiate with suppliers to meet business needs
• Coordinate all facets of projects with clients; build and maintain strong client relationships
• Serve as the primary contact for all data management study-specific issues, overseeing the entire data management process from study set-up to close-out
• Participate in protocol review with clients, providing suggestions for capturing protocol information in the database
• Maintain a strong understanding of GCP/ICH guidelines and FDA regulations as they apply to data management
• Create training exercises; mentor and train new clinical data managers
• Provide oversight and resolve issues in data management study processing activities, including CRF tracking, data entry, integration of external electronic data, data validation and review, query processing, adverse event and medication coding, SAE reconciliation, database lock, and QC audits
• Develop and oversee data management study documentation, including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plans
• Prepare study tracking and metric reports for the study team
• Oversee execution of user acceptance testing (UAT) of study-specific systems and applications
• Collaborate with cross-functional team members to ensure timely completion of studies
• Participate in data management and/or organizational initiatives
• Initiate SOP updates and provide specifications for DM systems/tools and process enhancements
• Act as a resource for QC activities in collaboration with the QC Coordinator
• Follow project management processes for data management projects (e.g., updating PSS, close-out procedures)
• Lead data management projects with minimal oversight; work independently to resolve issues
• Articulate the DM services offered at MMS, including pros and cons of various DM approaches for clients or operating models (may include attending capabilities and bid defense meetings)

Requirements

• Bachelor’s or Master’s Degree in a scientific or healthcare field preferred, with industry or relevant experience
• 5+ years of experience in the data management field, 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 skills, as well as strong interpersonal and organizational skills