Clinical Data Manager
New
P
PenumbraClinical research
Your Remote US Home OfficeTemporaryMiddle
Salary50 - 80 USD per hour
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Job Details
- Experience
- Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO); or an equivalent combination of education and experience. Preferred: Master’s degree with 3+ years of clinical research.
- Required Skills
- Project ManagementMicrosoft ExcelPowerPoint
Requirements
- Bachelor's degree and 5+ years of experience in a medical device, pharmaceutical company, or similar environment such as a CRO, or an equivalent combination of education and experience.
- Experience working on regulatory trials in the medical device and/or pharmaceutical industry.
- Experience with systems used for electronic capture of clinical trial data, such as iMedidata Rave, InForm, eClinicalOS, or RedCap.
- Thorough knowledge of clinical data management practices and in-depth understanding of data management activities.
- Knowledge of regulatory guidelines related to data quality and data management.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Knowledge of continuous improvement, project management, change management, and risk management.
- Ability to manage change and multiple priorities and work independently.
- Master’s degree and 3+ years of clinical research experience are preferred.
- CCDM certification is a plus.
Responsibilities
- Lead or perform data management activities for assigned studies, including startup, conduct, closeout, and reporting.
- Serve as the data management subject matter expert on multidisciplinary project teams.
- Identify data management deliverables and resource requirements, and contribute to project timelines.
- Monitor the progress and quality of data management activities.
- Oversee data management CROs and other vendors for compliance with protocols, standards, and regulatory guidelines.
- Ensure data management documentation is filed and archived according to company and regulatory requirements.
- Coordinate with data management, biostatistics, Clinical Affairs, and Medical Affairs teams to support data integrity and quality.
- Create training materials and train CRAs and other teams on data entry and data management practices.
- Use reports to track study progress and ensure timelines and quality expectations are met.
- Participate in audits and inspections and contribute to departmental process improvements.
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