Clinical Data Manager II
New
P
Precision for MedicineClinical research
Remote, United StatesFull-TimeMiddle
SalaryReasonable estimate of the current range $100,700 — $166,100 USD
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Job Details
- Languages
- Must read, write, speak fluently, and comprehend English.
- 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.
- Ability to read, write, speak fluently, and comprehend English.
- Ability to undertake occasional travel.
- Understanding of dictionary medical coding, including MedDRA and WHODrug, preferred.
- Understanding of CDISC standards, including CDASH, SDTM, and ADaM, preferred.
- Oncology therapeutic experience preferred.
Responsibilities
- Serve as the lead data management contact or contributor for assigned clinical projects, ensuring continuity and timely completion of tasks.
- Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
- Assist with clinical database builds, conduct database build UAT, maintain controlled documentation, and oversee database quality.
- Specify edit-check requirements and create, revise, version, and maintain data management documentation.
- Review and query clinical trial data according to the Data Management Plan, including line-listing review.
- Run patient- and study-level status and metrics reporting, and troubleshoot operational issues using metrics, audit reports, and stakeholder input.
- Perform medical coding and coordinate SAE/AE reconciliation.
- Coordinate with third-party data and EDC vendors on timelines and data-related deliverables.
- Train clinical research personnel and project team members on study-specific CRFs, EDC, and related project requirements.
- Communicate with sponsors, vendors, and project teams about data, database, and other project issues.
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