Clinical Data Manager

Penumbra; United States; Remote; USD 41,000 - 68,000; Part time

Job summary

Penumbra is seeking a temporary Clinical Data Manager to serve as the lead data manager on one or more clinical trials. The role supports study startup, conduct, closeout, and reporting, acting as the data management SME on cross-functional teams to develop timelines and deliverables.

You will oversee data management activities, coordinate with CROs and vendors per GCP and SOPs, and ensure proper archiving and documentation.

Responsibilities

• Independently lead and/or perform all data management activities within an assigned study (e.g., study startup, study conduct, study closeout, and reporting).
• Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements.
• Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities.
• Provide oversight for Data Management CRO and other vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, and other relevant guidelines.
• Ensure Data Management documentation is filed/archived according to applicable Penumbra and regulatory requirements.
• Interact with data management, biostatistics, Clinical Affairs and Medical Affairs team to ensure integrity and quality of data.
• Contribute ideas to the development of the department, identifying areas for improvement (e.g., SOPs, processes)
• Participates in audits and inspections.
• Attend Investigator Meetings when requested to provide training on CRF data completion.
• Responsible for creation of training mat

Job description

General Summary

The temporary Clinical Data Manager acts as a lead data manager for one or more projects, applies data management experience to clinical trials, and utilizes functional knowledge of the logistics of clinical trials to ensure the quality and integrity of clinical trial data. The CDM works on multi-functional teams and supports clinical trial projects as a departmental subject matter expert (SME). We are seeking a temporary clinical data manager who can dedicate 20 hours a week to support ongoing study activities. The initial assignment is for 6 months, but may be extended to meet the needs of our Team. Applicants must be eligible to live and work in the US.

Specific Duties and Responsibilities

• Independently lead and/or perform all data management activities within an assigned study (e.g., study startup, study conduct, study closeout, and reporting).
• Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements.
• Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities.
• Provide oversight for Data Management CRO and other vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, and other relevant guidelines.
• Ensure Data Management documentation is filed/archived according to applicable Penumbra and regulatory requirements.
• Interact with data management, biostatistics, Clinical Affairs and Medical Affairs team to ensure integrity and quality of data.
• Contribute ideas to the development of the department, identifying areas for improvement (e.g., SOPs, processes)
• Participates in audits and inspections.
• Attend Investigator Meetings when requested to provide training on CRF data completion.
• Responsible for creation of training mat