Manager, Clinical Data Management

SUMMARY:

Responsible for technical, managerial, and administrative functions of the Clinical Data Management System (CDMS), its associated procedures, and systems integrated with the CDMS. Works with the study teams and head of Data Management (DM) department to ensure consistency, efficiency, and compliance of day to day DM activities including data review, project support, and study document management. The Manager provides SME support with DM-related vendor audits, as well as authoring, review, and revision of Insmed SOPs. All duties are performed in compliance with protocol, data standards, SOPs, and regulatory requirements. The Manager is expected to undertake departmental initiatives improving/optimizing processes and implementing best practices, as well as be a positive role model for DM.

Responsibilities

• Review protocols from the perspective of ensuring the database development, data cleaning, and reporting requirements can be met and are standardized across the program
• Review DM documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, CRF Completion Guidelines, and other study documents to ensure quality and standardization; anticipate potential issues and address resolution or suggest risk minimization methods applicable to the situation
• Review and provide input for Statement of Work, TORO; contribute on assessment of vendor qualification, as applicable
• Work with vendor(s) in preparation of regulatory submissions, particularly to support the DM tasks such as transfer of data, review of data mapping/data conversion plan, review of SDTM/ADaM datasets, process for preparing ISS/ISE, etc.
• Develop, review and revise global SOPs; provide team training, where applicable
• Oversee the development of and compliance with global library standards
• Oversee the configuration designations, validation, and efficient use of the CDMS; proactively identify training needs and work to facilitate delivery
• Facilitate/respond to CAPAs related to DM
• Designated backup for head of DM
• Ensure high quality DM services through efficient and compliant processes

Qualifications

• Minimum 10 years of clinical DM experience in a biotech, pharmaceutical, or CRO environment
• Minimum 3 years of prior management experience preferred
• Bachelor’s Degree in scientific or technical discipline required, advanced degree preferred
• Experience with all aspects of DM including Database Build, Study Startup, Study Conduct, and Database Closure activities required
• Hands on experience with Electronic Data Capture systems required (current Medidata Rave desired) and ad hoc query tools required (JReview, other desired)
• Experience in CRO and vendor management required
• Experience with multiple phases of clinical development (e.g., Ph I-IV)
• Experience contributing on SOPs required
• Expert level proficiency in DM systems, processes, tools, and procedures
• Authored DM documents (Data Management Plan, Data Validation Specifications/ Plan, Data Review Plan, CRF Completion Guidelines, Data Transfer Agreements, etc.)
• Designed CRFs against study protocol
• Performed database UAT testing and prepared documentation
• Conducted data reviews
• Experienced with coding and data standards
• Audited and filed DM documents in designated study repository (highly desirable)
• Locked databases
• Must have excellent communication skills (verbal and written)
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
• Strong collaboration skills regarding external and internal teams, and working in a cross functional team environment
• Demonstrated ability to prioritize work
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• May require Domestic and/or International travel (some overnight), 15% of work time maximum
• Must successfully exhibit Insmed’s 5 core corporate competencies of: Excellence,
• Accountability, Driven, Collaborative, and Solutions; along with any other position-specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.