Remote Clinical Data Manager - Lead DM for Trials

pofft Technology Inc.; USA; Remote; USD 39.000 - 55.000; Teilzeit

Zusammenfassung

Penumbra is seeking a temporary Clinical Data Manager to lead data management activities for one or more clinical studies. The role supports trial teams remotely from a US home office and requires 20 hours per week with an initial 6-month assignment that may be extended.

Applicants must be eligible to live and work in the United States. The ideal candidate brings 5+ years in medical device/pharma DM, strong EDM experience (Rave/InForm/eClinicalOS/REDCap), and a track record of regulatory

Qualifikationen

• Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO)
• Master’s degree with 3+ years of clinical research preferred
• CCD M certified preferred
• Experience with electronic data capture systems (Rave, InForm, eClinicalOS, RedCap) is required
• Regulatory trial experience in medical device/pharma environment preferred

Aufgaben

• Lead data management activities within assigned study, from startup to closeout
• Serve as data management SME on cross-functional project teams
• Create and monitor project timelines and DM deliverables
• Oversee DM CROs and other vendors for compliance with SOPs and GCPs
• Ensure DM documentation is filed according to regulatory requirements
• Coordinate with DM, biostatistics, Clinical Affairs and Medical Affairs teams to ensure data integrity
• Provide DM training and SOP/process improvements
• Participate in audits and inspections
• Train CRAs to ensure consistent data entry at sites
• Adhere to QMS and regulatory standards

Kenntnisse

exec sys admin

infosec

education

technical

customer support

travel

excel

sales

biotech

medical

Ausbildung

Bachelor's degree

Master’s degree

Tools

iMedidata Rave

InForm

eClinicalOS

RedCap

Jobbeschreibung

Penumbra is seeking a temporary Clinical Data Manager to lead data management activities for one or more clinical studies. The role supports trial teams remotely from a US home office and requires 20 hours per week with an initial 6-month assignment that may be extended.

Applicants must be eligible to live and work in the United States. The ideal candidate brings 5+ years in medical device/pharma DM, strong EDM experience (Rave/InForm/eClinicalOS/REDCap), and a track record of regulatory