Ascentage Pharma · 3 weeks ago
Associate Director, Clinical Database/EDC Programming
Rockville, MD
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
8+ years expAscentage Pharma is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. The Associate Director of Clinical Database/EDC Programming will lead the design and governance of clinical database systems, ensuring regulatory compliance and driving standardization across Data Management.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
Lead the design, build, testing, maintenance, and administration of clinical databases and EDC systems, including eCRFs, edit checks, derivations, dictionaries, and standard/custom reports
Develop, maintain, and govern global library standard objects to enable efficient and consistent study-level database builds
Oversee user, role, and site administration, including permissions and training requirements
Build, implement, and maintain automated Serious Adverse Event (SAE) reporting solutions (e.g., Rave Safety Gateway), including data mapping and system integrations
Manage EDC system implementations, integrations, upgrades, releases, and patches in compliance with change control and validation requirements
Establish and maintain EDC programming governance, including SOPs, work instructions, templates, and best practices
Provide technical expertise and issue resolution support to cross-functional stakeholders and system users
Serve as a subject matter expert in vendor evaluation, selection, oversight, and audits related to EDC systems and programming services
Monitor emerging technologies and industry best practices to drive innovation, automation, and continuous improvement within Data Management
Provide technical oversight of external vendors and line management, training, and mentorship of EDC programming staff, as assigned
Qualification
Required
Bachelor's degree in Computer Science or related field
8–10 years of clinical database/EDC programming experience, including a minimum of 5 years of hands-on Medidata Rave EDC programming
Medidata Rave Developer certification
Demonstrated experience with Medidata Rave applications (e.g., Rave Coder, Lab Administration, Safety Gateway)
Proficiency in one or more programming languages (e.g., C#)
Experience with other EDC platforms (e.g., Veeva EDC, Oracle Inform, Medrio)
Experience with reporting and analytics tools (e.g., J-Review, Spotfire, Cognos, Business Objects)
Strong understanding of relational databases, data integration concepts (e.g., ODM, APIs), SDLC, and computerized systems validation
Working knowledge of FDA regulations and industry standards (GCDMP, ICH/GCP, 21 CFR Part 11)
Preferred
Master's degree
Java and HTML
Familiarity with SAS and CDISC standards (CDASH/SDTM)
Experience managing and mentoring direct reports
Benefits
Exceptional, Medical, Dental, and Vision plans for employees and families
Employee paid life, STD & LTD as well as a comprehensive insurance package with spouse life Insurance, Critical Illness, and Accident Insurance
401K with a 6% company match
Liberal paid time off
Flexible schedules for staff and employee assistance program
Company
Ascentage Pharma
Ascentage is a clinical-stage biopharmaceutical company that develops drugs for the treatment of cancer.
201-500 employees
H1B Sponsorship
Ascentage Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
2022 (2)
2021 (1)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$504.74MKey Investors
TakedaYuanMing CapitalSDIC Fund Management
2025-07-14Post Ipo Equity· $192.26M
2024-06-20Post Ipo Equity· $75M
2019-10-28IPO
Leadership Team
Yifan Zhai
Chief Medical Officer
Recent News
2026-01-06
2025-12-05
2025-11-11
Company data provided by crunchbase