Senior Clinical Database Designer
Primary Location: United States, Baltimore, Maryland Job ID R0000037637 Category Data ManagementAbout this Role
Key Accountabilities:
Set-up studies in ClinBase ™
- Lead, supervise and/or create, implement and execute user defined procedures specific procedures/pages/templates/screens to build and maintain database set-ups.
- Create (EDC) clinical data management systems in a standard format as required, including Setup Output Files, Report (e.g. CRFs), where applicable.
- Lead, supervise and/or create, implement and maintain consistency checks in standard, data capture format for database builds, following and understanding internal and external regulatory requirements.
- Accountable for first time quality on all deliverables. Participate in the review process of the clinical study protocol, protocol amendments and other study related documents as applicable.
Business Strategy Support and Communication
- Assist in providing technical solutions to internal or external client enquires in terms of EDC study setups and designs.
- Develop wider knowledge of areas of Clinical Data Base Systems, Electronic Data Capture (EDC), Clinical Trial Management
- Ensure adherence to setup timeline and agreement on database finalization
Documentation
- Maintain specific “EDC” study setup and supporting documentation for studies in accordance with SOPs/ other Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
- Maintain technical documentation that is applicable to the Clinical EDC Database system.
Support Initiatives
- Participate in the creation of standards, either through tools, libraries or processes, as required for EDC to ensure efficient, effective and optimal processes.
- Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.
- Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial
Mentoring
- Provide relevant training and mentorship to staff and project teams as appropriate.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work.
- Assist in providing technical solutions to internal or external client enquires.
- Maintain and expand local and international regulatory knowledge within the clinical industry.
Training
- Compliant with Study and Sponsor specific training as applicable.
- Complaint with all Corporate training as applicable.
- Compliant with mandatory ICH-GCP training and awareness of Health and Safety as applicable.
- Assist study team, when necessary, on the set-up, review and release processes for ClinBase™.
Skills:
- Excellent English written and oral communication skills.
- Demonstrate ability to learn new systems and function in an evolving technical environment.
- Excellent attention to detail.
- Ability to work together with a team (including international teams as required) as well as independently.
- Work effectively in a quality-focused environment.
- Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
- Business/Operational skills that include customer focus, commitment to quality management and problem solving.
- Good business awareness/business development skills (including financial awareness).
- Strong leadership ability.
- Demonstrate commitment to refine quality processes.
Knowledge and Experience:
- Interest and aptitude for Clinical Research
- Computer literacy essential. (e.g. Word, Outlook, PowerPoint and Excel)
- Experience of working in a multi-disciplinary team
- Experience in supporting counterparts and peers
- Understanding of EDC and other eCRF systems
- Understanding the importance of data Integrity in the progression of Clinical Research.
Education:
- Bachelor of Science/Master of Science in a health related, science or equivalent experience.
Minimum Work Experience:
- At least 5 years, clinical and /or research experience in the setup of any EDC preferred.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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