Description

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?

About the Role:
We're looking for a Senior Clinical Data Manager on the Biometrics team to help us expand what's possible for patients with serious diseases. Reporting to the Associate Director, Clinical Data Management, you'll have responsibility for the direct management and oversight of data management activities for assigned studies. You'll work in conjunction with the study team to ensure data review, project support, study document management and oversight of DM timelines, EDC/IWRS setup, study database design, clinical data capture, discrepancy management and data reconciliation. This position is remote and can be located anywhere in the United States.

What You'll Do:

In this role, you'll have the opportunity to be the primary point of contact between Data Management and the clinical team with respect to the management and oversight of date management activities. . You'll also:

• Author, review/revise Data Management related study plans including Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines and other study documents to ensure quality and standardization
• Collect approvals and provide authorization on DM deliverables including but not limited to finalized DM documents, database release to production and database lock
• Work with vendor(s) particularly to support the DM tasks such as transfer of data
• Manage design and development of eCRFs, including database UAT
• Oversee and manage the development and implementation of edit check specifications and work with database programmers during programming and validation
• Manage and oversee data management related activities for the ongoing study
• Lead DM study meetings; distribute agenda, create minutes capturing action items and decisions
• Lead data reviews with clinical team to ensure accuracy, consistency and reliability of data
• Review database metrics and follow escalation process to achieve resolution of noted issues
• Collaborate with study team to ensure study databases are locked based on pre-defined criteria and timelines

Who You Are:

You have a Bachelors degree along with 5 years of experience in biotech, pharmaceutical or CRO environment (or equivalent).

You are or you also have:

• Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities
• 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 trial phases of clinical development

#LI-TB1

#LI-Remote

Pay Range:
$113,000.00-143,500.00 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.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.