Seneca Resources Company, LLC · 5 hours ago
Clinical Database Developer
Fort Detrick, MD
Contract
Hybrid
Senior Level
5+ years expSeneca Resources Company, LLC is a staffing and consulting firm that partners with various organizations. They are seeking a Clinical Database Developer to oversee and perform tasks across multiple clinical trials, ensuring compliance with regulatory standards while collaborating with interdisciplinary teams.
Oil & Energy
No H1B
Security Clearance RequiredU.S. Citizen Only
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 with multidisciplinary teams including regulatory, clinical, biostatistics, and technical stakeholders in a highly regulated environment
Qualification
Required
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
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
Working knowledge of 21 CFR 312 / 812
Working knowledge of ISO 14155
Working knowledge of 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
Preferred
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)
Benefits
Comprehensive health, dental, and vision coverage
401(k) retirement plans
Company
Seneca Resources Company, LLC
Seneca Resources Company, LLC, the exploration and production segment of National Fuel Gas Company, headquartered in Houston, Texas, explores for, develops, and produces natural gas in the Appalachian Region including the Marcellus and Utica Shales.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John McGinnis
Chief Operating Officer
Todd Abbott
Chief Operating Officer
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