Principal Clinical Data Manager
New
E
eClinical SolutionsPharmaceutical / Biotechnology
Location: RemoteFull-TimeSenior
Salary125,000 - 145,000 USD per year
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Job Details
- Languages
- English
- Experience
- 10+ years
- Required Skills
- Project ManagementData AnalysisMicrosoft Excel
Requirements
- Bachelor’s degree or higher in a relevant health science or scientific/technical discipline.
- 10+ years of experience in the Pharmaceutical/Biotechnology industry in Clinical Data Management or equivalent consulting.
- Strong project management experience including work planning, delegation, and complex problem solving.
- Demonstrated command of the English language with proficiency in verbal and written communication.
- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel.
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology.
- Proficient with EDC and Clinical Data Management Systems.
- Exposure to CDISC guidelines and standards.
- CCDM Certification (preferred).
- Experience with Agile and Six Sigma methodologies (preferred).
- Experience with Cloud SaaS platforms (preferred).
- Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred).
- Experience with RBQM methodology (preferred).
Responsibilities
- Serve as primary representative for eClinical Solutions and sponsor data management interactions.
- Function as DM subject matter expert providing guidance on best practices, technology, and solutions.
- Manage study requirements including protocol conversion, database build, CRF design, and query management.
- Define specifications and collaborate on the configuration of elluminate for data cleaning strategies.
- Perform quality control on team deliverables, study documents, and report specifications.
- Execute quality oversight and data trending using elluminate reporting and analytics to identify risks.
- Collaborate with technical and engineering teams to develop tech-enabled solutions for process efficiency.
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