Associate Director, Clinical Data Management

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

What You'll Do:

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, This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

You have a Bachelor's degree along with <# of minimum years of experience> years of clinical data management experience in a biotech, pharmaceutical or CRO environment.

You are or you also have:

• Three (3) years of prior management experience
• Hands-on experience with Electronic Data Capture systems (Medidata Rave required) essential
• Experience in CRO and vendor management required, 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

Nice to have (but not required):

• Advanced degree

3.83.8 out of 5 stars Bridgewater, NJ 08807 Remote $164,000 - $213,000 a year - Full-time, Pulled from the full job description

• Employee stock purchase plan
• Health insurance
• 401(k) matching
• Paid time off
• Vision insurance
• Dental insurance
• Life insurance, $164,000.00-213,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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 with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we're in. Are you?