Clinical Database Developer

About This Role

Serve as a hands-on performer and oversight resource for clinical database development across multiple clinical trials, supporting all phases of the clinical data management lifecycle. This role involves close collaboration with multidisciplinary teams in a highly regulated environment.

Responsibilities

• Serve as a hands-on performer and oversight resource across multiple clinical trials
• Support all phases of the clinical data management lifecycle from study startup through database lock and archival
• Collaborate closely with multidisciplinary teams including regulatory, clinical, biostatistics, and technical stakeholders
• Design, develop, test, validate, and maintain protocol-specific clinical databases
• Create and maintain Data Management Plans (DMPs), Data Validation Plans (DVPs), eCRFs/CRFs, database specifications, and validation documentation
• Support UAT, production releases, database lock/unlock, and study closeout
• Provide technical support to end users for protocol-specific databases
• Initiate, log, track, and resolve technical issues
• Review SOPs, policies, work instructions, and validation documentation

Requirements

• Minimum 5 years of clinical database development experience
• Demonstrated experience providing clinical research data management oversight
• Experience supporting FDA-regulated clinical trials
• Hands-on experience with Inform GTM
• Strong experience with Electronic Data Capture (EDC) systems
• Experience with Central Designer
• Experience working with Oracle databases
• Experience designing, developing, testing, validating, and maintaining protocol-specific clinical databases
• Experience creating and maintaining Data Management Plans (DMPs)
• Experience creating and maintaining Data Validation Plans (DVPs)
• Experience creating and maintaining eCRFs / CRFs
• Experience creating and maintaining Database specifications and validation documentation
• Experience supporting UAT, production releases, database lock/unlock, and study closeout
• Familiarity with clinical data standards (CDASH, SDTM, SDTMIG-MD, controlled terminology)
• Working knowledge of 21 CFR Part 11, 21 CFR 312 / 812, ISO 14155, GCP, GCDMP, and ICH guidelines
• Experience providing technical support to end users for protocol-specific databases
• Ability to initiate, log, track, and resolve technical issues
• Experience reviewing SOPs, policies, work instructions, and validation documentation
• Strong written and verbal communication skills
• Ability to collaborate across interdisciplinary teams and external vendors
• U.S. Citizenship required

Qualifications

• Bachelor’s degree in computer science or a related discipline OR an equivalent combination of education, professional training, and experience
• Minimum 5 years of clinical database development experience

Nice to Have

• Experience with MRDC in-house Clinical Research Data Management System (CRDMS)
• Experience supporting integrations (IRT, eCOA, Central Labs, PK data)
• Experience with medical coding and clinical data reporting/exports (SAS, Excel)

Skills

* Required skills

Benefits