Associate Director, Clinical Data Management

Compensation

$164,000.00 - $164,000.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Job 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 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

Who You Are:

You have a Bachelor's degree along with 6+ 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

Where You'll Work

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.

Travel Requirements

This role requires occasional domestic/international travel (approximately 15%)

#LI-JK

#LI-Remote

Pay Range:

$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.

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 View email address on click.appcast.io 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.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

A reasonable accommodation, if one is available under applicable law, by emailing View email address on click.appcast.io ; and/or

An alternative selection process by emailing View email address on click.appcast.io .

Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at View email address on click.appcast.io .

Apply here:

Place of Work

On-site

Requisition ID

R3563-3486