Clinical Data Manager (Temporary Position, 20 hours/week)
Penumbra
Opportunity published from Lever · applications stay with the original hiring source.
About the opportunity
- The temporary Clinical Data Manager acts as a lead data manager for one or more projects, applying data management experience to clinical trials and utilizing functional knowledge of trial logistics to ensure data quality and integrity.
- This is a temporary position requiring 20 hours per week for an initial 6-month assignment, with the possibility of extension. Applicants must be eligible to live and work in the US.
- The role involves working on multidisciplinary teams as a departmental subject matter expert, overseeing data management CROs and vendors, and adhering to the Company Quality Management System and relevant regulations.
Key responsibilities
- Independently lead and/or perform all data management activities within an assigned study, including study startup, conduct, closeout, and reporting.
- Serve as the data management subject matter expert on multidisciplinary project teams, providing expertise on timeline development, deliverables, and resource requirements.
- Provide oversight for Data Management CROs and other vendors to ensure compliance with protocols, standards, Good Clinical Practices, and regulatory guidelines.
- Interact with data management, biostatistics, Clinical Affairs, and Medical Affairs teams to ensure data integrity and quality.
- Create training materials and train CRAs and site personnel on CRF data completion to ensure consistency of data entry.
- Utilize reports to track study progress, ensure timeliness and quality expectations are met, and adhere to the Quality Management System and relevant security, privacy, and compliance principles.
- Ensure proper filing and archiving of Data Management documentation according to Penumbra and regulatory requirements.
Qualifications
- Bachelor's degree with 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.
- Must have strong experience with systems used for electronic capture of clinical trial data, such as iMedidata Rave, InForm, eClinicalOS, and RedCap.
- Must have experience working on regulatory trials within the medical device and/or pharmaceutical industry.
- Thorough knowledge of effective clinical data management practices and regulatory guidelines pertaining to data quality and management.
- Technical, organizational, analytical, and strong communication skills with the ability to operate independently and manage multiple priorities.
- Proficiency with MS Word, Excel, and PowerPoint.
- Applicants must be eligible to live and work in the US.
Nice to have
- Master’s degree with 3+ years of clinical research or pharmaceutical company experience.
- CCDM certified professional.
- Knowledge of continuous improvement, project management, change management, and risk management.
Base Pay Range Per Hour
$50.00 - $80.00, with individual compensation varying based on qualifications, skill level, competencies, and work location.
Job details
- Location: General office environment with a willingness and ability to work on-site, including potential business travel from 0% - 5%.
- Schedule: Temporary, 20 hours per week, 6-month initial assignment.
Physical Requirements
- Potential exposure to blood-borne pathogens, lifting and moving up to 25 pounds, moving between buildings and floors, and remaining stationary using a computer or office equipment for extensive periods.
- Application: UpVagas lists this opportunity from the hiring company or its recruitment platform. The application is completed at the original source.
Full listing
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