Ascentage Pharma
Overview
Ascentage Pharma (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. Ascentage Pharma is proud of its collaborative and supportive culture, unified by a shared desire to develop therapeutics that will have a positive impact on patients’ lives. Located in the USA, China, UK and Australia, we leverage our expertise in structure-based drug design and our innovative drug discovery engine. Position Summary
Reporting to the Senior Director, Data Management, the Sr. Mgr. Clinical Database/EDC Programming is responsible for the design, implementation, and governance of clinical database and EDC systems supporting Ascentage Pharma’s clinical studies. This role provides technical leadership, ensures regulatory-compliant data acquisition solutions, and drives standardization, efficiency, and automation across Data Management. Location
Preferred location is Washington, DC, Maryland (including Baltimore), or Northern Virginia. However, remote consideration will be offered for a highly qualified candidate. Key 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. Qualifications
Bachelor’s degree in Computer Science or related field; Master’s degree preferred. 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 required. Demonstrated experience with Medidata Rave applications (e.g., Rave Coder, Lab Administration, Safety Gateway). Proficiency in one or more programming languages (e.g., C#); Java and HTML preferred. 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). Familiarity with SAS and CDISC standards (CDASH/SDTM) preferred. Experience managing and mentoring direct reports preferred. Culture
Establish a collaborative, energized, and fun work environment where people are empowered and supported in the achievement of their career goals. Create a diverse and multi‑disciplinary workforce where all levels of the organization are empowered to lead best welcomes innovation and support career goals. Hire dedicated, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, with a commitment to science and to the patients we serve. Compensation and Benefits
Ascentage Pharma offers an extremely competitive compensation package, including an annual bonus. 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. 401(k) with a 6% company match. Liberal paid time off. Flexible schedules for staff and employee assistance program. EEO Statement
Ascentage Pharma is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is Ascentage Pharma's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, marital status, status as a protected veteran, or any other legally protected group status.
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Ascentage Pharma (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. Ascentage Pharma is proud of its collaborative and supportive culture, unified by a shared desire to develop therapeutics that will have a positive impact on patients’ lives. Located in the USA, China, UK and Australia, we leverage our expertise in structure-based drug design and our innovative drug discovery engine. Position Summary
Reporting to the Senior Director, Data Management, the Sr. Mgr. Clinical Database/EDC Programming is responsible for the design, implementation, and governance of clinical database and EDC systems supporting Ascentage Pharma’s clinical studies. This role provides technical leadership, ensures regulatory-compliant data acquisition solutions, and drives standardization, efficiency, and automation across Data Management. Location
Preferred location is Washington, DC, Maryland (including Baltimore), or Northern Virginia. However, remote consideration will be offered for a highly qualified candidate. Key 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. Qualifications
Bachelor’s degree in Computer Science or related field; Master’s degree preferred. 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 required. Demonstrated experience with Medidata Rave applications (e.g., Rave Coder, Lab Administration, Safety Gateway). Proficiency in one or more programming languages (e.g., C#); Java and HTML preferred. 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). Familiarity with SAS and CDISC standards (CDASH/SDTM) preferred. Experience managing and mentoring direct reports preferred. Culture
Establish a collaborative, energized, and fun work environment where people are empowered and supported in the achievement of their career goals. Create a diverse and multi‑disciplinary workforce where all levels of the organization are empowered to lead best welcomes innovation and support career goals. Hire dedicated, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, with a commitment to science and to the patients we serve. Compensation and Benefits
Ascentage Pharma offers an extremely competitive compensation package, including an annual bonus. 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. 401(k) with a 6% company match. Liberal paid time off. Flexible schedules for staff and employee assistance program. EEO Statement
Ascentage Pharma is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is Ascentage Pharma's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, marital status, status as a protected veteran, or any other legally protected group status.
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