Job Details

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 four 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: The Associate Director, EDC Programming will lead and oversee EDC programming, and database build for in-house clinical trials. This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency throughout the study lifecycle. The AD, EDC Programming will perform optimized EDC builds using established standards and efficient processes in the implementation and integration of patient data systems. The candidate will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.

What You'll Do:

EDC System Design & Development: Lead the setup, development, and validation of EDC systems, including configuration settings, integration with other applications, and subsequent updates. Create and maintain study databases, including eCRF design, edit checks, and custom functions in a timely manner with high quality. Collaborate with cross-functional teams to ensure study requirements are adequately defined and help translate them into functional EDC specifications. Collaborate with Medidata support and internal teams to troubleshoot and optimize platform performance. Medidata Rave Expertise: Serve as the subject matter expert (SME) for Medidata Rave, providing technical guidance and support to the team. Review software upgrades and database releases for impact to configurations. Provide support to DMs in creation of data listings using RAVE tools (e.g., Business Objects, other) and non-RAVE tools/applications (e.g., JReview, other). Facilitate/ support troubleshooting and resolution of technical issues related to Medidata Rave. Programming & Integration: Partner with internal data teams to support automation, reporting, and data exchange solutions. Ensure all programming solutions comply with GCP, 21 CFR Part 11, and CDISC ODM Standards. Data Quality & Compliance: Ensure EDC systems comply with regulatory requirements (e.g., FDA, EMA, ICH-GCP) and company SOPs. Perform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity and accuracy. Implement and monitor data quality checks to identify and resolve discrepancies. Collaborate with partners (e.g., DSQA, CSV, CQA, other) to maintain compliance with EDC systems and associated applications. Support audits and inspections by providing technical expertise and system documentation. Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development. Team Leadership & Collaboration: Mentor and guide junior EDC programmers, fostering innovation, accountability, and continuous learning. Collaborate with external vendors and CROs to ensure seamless integration of EDC systems. Provide training and support to end-users on Medidata Rave, other EDC tools, and emerging technologies. Process Improvement: Identify opportunities to streamline EDC programming processes and improve efficiency. Stay updated on industry trends and advancements in EDC technologies, particularly Medidata Rave. Contribute to the development and implementation of best practices for EDC programming. Develop and contribute on SOP creation. Who You Are: Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related field. Advanced degree preferred. Minimum of 7+ years of experience in EDC programming, configuration, and management of EDC systems, with at least 5 years of hands-on experience with Medidata Rave. Proven track record of leading EDC system design and implementation for clinical trials. Advanced proficiency in the broader Medidata Clinical Cloud suite (e.g., Rave EDC, Rave Coder, Lab Administration, RTSM, eCOA, TSDV, RSG, and Designer) would be strongly desirable. In-depth knowledge of regulatory requirements (e.g., FDA, EMA) and clinical development processes. Advanced proficiency in custom function programming, using C# is desirable. Preferred proficiency in Python, C#, and JSON to support custom database integration programming, automation, development of custom tools, and data exchange solutions that enhance clinical trial efficiency. Solid understanding of CDISC standards (CDASH, SDTM) and regulatory requirements for clinical data. Experience with programming languages such as SQL, SAS, or Python is a plus. Problem-solving skills, attention to detail, and the ability to work in a fast-paced, collaborative environment! Strong communication and interpersonal skills, with the ability to collaborate effectively across teams! Preferred experience in gene therapy and familiarity with biometrics technology software tools. Pay Range: $147,000.00-206,333.00 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.

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.

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.

Company

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

CONNECT

Company info Website https://insmed.com/ Phone (908)977-9900 Location 700 US Highway 202/206 Bridgewater New Jersey 08807 United States

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