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Job Description
- Design, develop, implement, maintain,and support clinical database systems.
- Offer technical expertise for internal and external clients.
- Code, test,and document databases as per programming standards and clinical validation policies.
- Program database manipulation and conduct data transfers for clients.
- Review Data Validation Plans and Case Report Forms as per area of expertise.
- Add all external data sources such as PK and central lab within the clinical database if integration is requested or required.
- Serve as programming contact to handle database issues within area of expertise.
- Support development and implementation of new technologies.
- Support Information Technology to evaluate new technology upgradesby participating in software change controls.
- Support development, revision and maintenance of core operating procedures and working instructionspertaining to database development, user acceptance testing and change controls
- Interface with project team to organize responsibilities and deliverables.
- Establish effective communication and professional relationships with teams and external vendors.
- Interface with Clinical Data Management and corporate team to negotiate timelines.
- Perform administrative tasks within the EDC system, such as site and user management, URL level reviews and/or approvals, and dictionary updates.
- Follow and influence the development of data standards and strategies pertaining to the standards library
Qualifications
- Minimum BS in a scientific or health related field or equivalent in years of experience.
- Minimum 3 years of experience as a clinical database developer with at least 5 years of experience leading a study build.
- Excellent programming skills in SAS and R, including designing and developing output tables, listings, and figures.
- Experience with EDC systems, preferably with ICD and Rave
- Understanding of the principles of ICH GCP and regulatory requirements is essential.
- Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.
Additional Information
All your information will be kept confidential according to EEO guidelines.