Clinical Data Manager II
New
P
Precision for MedicineClinical research
Location: Remote, United StatesFull-TimeMiddle
Salary$110,700 — $166,100 USD
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Job Details
- Languages
- Must be able to read, write, speak fluently and comprehend the English language
- Experience
- 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Bachelor’s degree and/or a combination of related experience.
- 5+ years of Clinical Data Management experience or demonstrated aptitude in the key skills for the role.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Experience using a clinical database management system.
- Broad knowledge of drug, device, and/or biologic development and effective data management practices.
- Ability to handle a variety of clinical research tasks.
- Strong organizational and communication skills.
- Fluency in reading, writing, speaking, and comprehending English.
- Ability to undertake occasional travel.
- Preferred: understanding of medical coding dictionaries, including MedDRA and WHODrug.
- Preferred: understanding of CDISC standards, including CDASH, SDTM, and ADaM.
- Preferred: oncology therapeutic experience.
Responsibilities
- Lead or contribute to data management for assigned clinical projects and programs, ensuring continuity and timely completion of tasks.
- Develop CRF specifications from study protocols and coordinate stakeholder review and feedback.
- Assist with clinical database builds, conduct user acceptance testing, and maintain controlled database documentation.
- Specify edit-check requirements and oversee clinical database quality.
- Create, revise, version, and maintain data management documentation and oversee its completeness in the Trial Master File.
- Review and query clinical trial data according to the Data Management Plan, including line-listing review.
- Run patient- and study-level status and metrics reports, and identify operational issues using metrics and audit reports.
- Perform medical coding and coordinate SAE/AE reconciliation.
- Coordinate with sponsors, vendors, and project teams on data, database, timelines, and deliverables.
- Train clinical research personnel and data management team members on study-specific CRFs, EDC, and related project items.
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