Lead Clinical Data Manager - Part-Time (20h/wk, 6mo)

Penumbra; United States; Remote; USD 69,000 - 110,000; Part time

Job summary

Penumbra is seeking a Temporary Clinical Data Manager to lead data management activities for one or more projects, ensuring data quality and integrity in clinical trials. The role focuses on creating timelines, overseeing vendors, and training site staff, with 20 hours per week for a 6-month initial assignment, located in the United States.

The ideal candidate will have a Bachelor's degree with 5+ years in medical devices or pharma CRO environments, strong data management knowledge, and

Qualifications

• Bachelor's degree with 5+ years in medical device, pharmaceutical company, or CRO environment.
• Strong knowledge of clinical data management practices.
• Experience with regulatory trials in medical device/pharma industries.
• Proficiency with MS Word, Excel and PowerPoint.

Responsibilities

• Lead and/or perform all data management activities within an assigned study.
• Serve as the data management SME on multidisciplinary project teams.
• Monitor progress of data management activities and timelines.
• Provide oversight for DM CROs and vendors for compliance with protocols and GCP.
• Ensure DM documentation is filed/archived per standards.
• Interact with DM, biostatistics, Clinical Affairs and Medical Affairs teams.
• Contribute ideas to improve DM processes and SOPs.
• Participate in audits and inspections.
• Attend Investigator Meetings to train on CRF data entry.
• Create training materials and train CRAs for data entry consistency.
• Provide DM department training to other teams as needed.
• Use reports to track study progress and ensure quality.
• Adhere to QMS and regulatory standards; ensure data security/privacy compliance.
• Ensure department adheres to QMS and regulations.
• Perform other related duties.

Skills

Data management

Timeline development

Vendor management

Audits & inspections

Training

GCP compliance

Education

Bachelor's degree

Master’s degree

CCD M certified

Tools

iMedidata Rave

InForm

eClinicalOS

RedCap

Job description

Penumbra is seeking a Temporary Clinical Data Manager to lead data management activities for one or more projects, ensuring data quality and integrity in clinical trials. The role focuses on creating timelines, overseeing vendors, and training site staff, with 20 hours per week for a 6-month initial assignment, located in the United States.

The ideal candidate will have a Bachelor's degree with 5+ years in medical devices or pharma CRO environments, strong data management knowledge, and