Temporary Lead Clinical Data Manager - 20h/Week

penumbrainc; United States; On-site; USD 25,000 - 60,000; Part time

Job summary

Penumbra seeks a temporary Clinical Data Manager to lead data management for one or more clinical projects. The role is a 6-month assignment with 20 hours per week, requiring eligibility to live and work in the United States and on-site presence.

The DM will oversee startup through closeout, act as SME on timelines and deliverables, manage DM vendors, and ensure QA/QMS compliance. Collaboration with cross-functional teams will ensure data integrity and regulatory adherence.

Qualifications

• Bachelor's degree with 5+ years in medical device/pharma environment.
• Experience leading data management activities in clinical trials.
• CCDM certification is a plus.
• Experience with electronic data capture systems (iMedidata Rave, InForm, eClinicalOS, RedCap).

Responsibilities

• Independently lead and/or perform all data management activities within an assigned study (startup, conduct, closeout, reporting).
• Serve as the data management SME on multidisciplinary project teams.
• Monitor progress of data management activities and timelines.
• Oversee DM CROs/vendors to ensure protocol compliance and regulatory standards.
• Maintain DM documentation per QMS and regulatory requirements.
• Collaborate with DM, Biostatistics, Clinical Affairs, and Medical Affairs to ensure data integrity.
• Attend investigator meetings to train on CRF data completion.
• Create training materials and train CRAs to ensure consistency of data entry at sites.
• Provide DM department training to other teams as needed.
• Use reports to track study progress and timeliness.

Skills

Communication skills

Analytical skills

Organizational skills

Change management

Regulatory knowledge

Education

Bachelor's degree with 5+ years in medical device/pharma environment

Master's degree with 3+ years of clinical research (preferred)

Tools

iMedidata Rave

InForm

eClinicalOS

REDCap

Job description

Penumbra seeks a temporary Clinical Data Manager to lead data management for one or more clinical projects. The role is a 6-month assignment with 20 hours per week, requiring eligibility to live and work in the United States and on-site presence.

The DM will oversee startup through closeout, act as SME on timelines and deliverables, manage DM vendors, and ensure QA/QMS compliance. Collaboration with cross-functional teams will ensure data integrity and regulatory adherence.