Senior Clinical Data Manager (Remote - US)

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry-best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.

About the role

Join us at MMS and be part of a team that is shaping the future of clinical research.

Responsibilities

• Confidently display excellent internal and external customer service
• Demonstrate proficiency and knowledge of multiple EDC systems; apply this knowledge to advise customers regarding the best-fit EDC solution
• Interact directly and independently with DM suppliers including EDC and/or IWR; act as expert communicator, negotiating with suppliers to meet business needs when necessary
• Interact directly and independently with clients to coordinate all facets of projects; build and maintain strong client contacts and relationships
• Serve as primary contact for the entire data management process from study set-up to study close-out; address all data management study-specific issues; possess high-level knowledge of drug development as it pertains to data management
• Actively participate in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully
• Maintain a 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
• Provide oversight and resolve all issues in data management study processing activities, including:
  • CRF tracking and data entry
  • Integration of external electronic data (e.g., lab data) with clinical database
  • 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)
  • 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/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 QC Coordinator
• Understand and follow processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.)
• Display 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 and resolve issues effectively
• Clearly articulate the DM services offered at the company, including pros and cons of various DM approaches (specific to a client or operating model), potentially attending (web or remote) 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 of experience 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