Associate Director, EDC Programming

Company Description

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.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2025, we became Great Place to Work-certified in the U.S. for the fifth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

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.

Responsibilities

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, an