[Hiring] Associate Director, Clinical Data Management @Insmed Incorporated

Role Description

We’re looking for an Associate Director, Clinical Data Management on the Clinical Data Management (CDM) team to help us expand what’s possible for patients with serious diseases. Reporting to the Head of Clinical Data Management, you’ll be responsible for working in conjunction with the Clinical Project Manager and study team to ensure data review, project support, study document management and CRO oversight of:

• DM timelines
• EDC/IWRS set up
• Study database design
• Clinical data capture
• Discrepancy management
• Data reconciliation

You will also provide SME support with Data Management related vendor audits, as well as authoring, review and revision of Insmed SOPs.

In this role, you’ll have the opportunity to review and provide input into protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the programs. You’ll also:

• Review/revise Data Management related study plans including Data Management Plan, Data Validation Plan and other study documents to ensure quality and standardization
• Manage and oversee data management related activities with CROs and other external vendors
• Work with vendor(s) in preparation of regulatory submissions, particularly to support the DM tasks such as transfer of data
• Develop, review and revise global SOPs providing team training where applicable
• Manage design and development of eCRFs, clinical review and communication with CRO
• Oversee and manage the development and implementation of edit check specifications and work with CRO during programming & validation
• Participate in monthly data reviews with clinical team to ensure accuracy, consistency and reliability of data
• Work with CROs and study teams to ensure study databases are locked based on pre-defined criteria and timelines
• Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner
• Provide high quality services through efficient and compliant processes

Qualifications

• Bachelor’s degree
• Minimum years of clinical data management experience in a biotech, pharmaceutical or CRO environment
• Three (3) years of prior management experience
• Hands-on experience with Electronic Data Capture systems (Medidata Rave required)
• Experience in CRO and vendor management, including vendor budgeting and auditing
• Experience in developing study documents and SOPs
• Experience with multiple phases of clinical development
• Excellent communication skills and ability to work in a cross-functional team environment
• Strong collaboration skills regarding external and internal teams

Requirements

• Nice to have: Advanced degree

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back