Senior Clinical Data Manager (Remote - US)

About the role

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 offer a collaborative and inclusive environment where your contributions truly matter and you can thrive alongside a supportive, innovative team with industry-leading retention.

Responsibilities

• Display excellent internal and external customer service.
• Apply proficiency in multiple EDC systems to advise customers on the best-fit EDC solution.
• Interact directly and independently with data management (DM) suppliers, including EDC and/or IWR, negotiating as needed to meet business needs.
• Coordinate all facets of projects through direct, independent client interaction; build and maintain strong client relationships.
• Serve as the primary contact for the entire data management process, from study set-up to close-out, including high-level knowledge of drug development as it pertains to data management.
• Actively participate in protocol review with clients, providing suggestions for successful database capture of protocol information.
• Maintain a strong understanding of GCP/ICH guidelines and FDA regulations applicable 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 (e.g., lab data), data validation and review, query processing, adverse event and medication coding, SAE reconciliation, database lock, and 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 Plans.
• Prepare study tracking and metric reports for the study team.
• Oversee execution of user acceptance testing (UAT) of study-specific systems and applications.
• Interact 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).
• Maintain a confident, positive attitude toward clients and projects.
• Demonstrate willingness to learn new skills and expand knowledge of drug development.
• Lead data management projects with minimal management oversight.
• Work independently to resolve issues.
• Clearly articulate DM services offered at MMS, including pros and cons of various DM approaches, and attend capabilities and bid defense meetings (web or remote).

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.