Clinical Data Manager - Medical Device & Pharma

The Briefed; Alameda (CA); Vor Ort; USD 69.000 - 110.000; Teilzeit

Benefits dieser Stelle

Competitive hourly pay

Zusammenfassung

Penumbra, Inc. in Alameda, CA seeks a Temporary Clinical Data Manager (CDM) to dedicate 20 hours per week across the trial lifecycle. You will lead data management across projects, ensuring data integrity under GCP and QMS requirements.

The role focuses on study startup through closeout, oversight of CROs, training of CRAs, and regulatory readiness, with emphasis on data accuracy and auditable documentation in cross-functional teams.

Qualifikationen

• Bachelor’s degree with 5+ years of clinical data management experience in medical devices, pharma, or CRO.
• Must be legally eligible to live and work in the United States.
• Experience with EDC platforms such as iMedidata Rave, InForm, eClinicalOS, REDCap.
• Experience leading data management for regulatory clinical trials in medical devices or pharmaceuticals.
• Knowledge of GCP and global regulatory guidelines pertaining to clinical data quality.

Aufgaben

• Lead end-to-end data management activities across trials—startup, conduct, database lock, closeout.
• Serve as Data Management SME on project teams, defining data deliverables and timelines.
• Oversee Data Management CROs and vendors to ensure SOPs and regulatory standards.
• Collaborate with Biostatistics, Clinical Affairs, and Medical Affairs to monitor progress and audit data quality.
• Create training materials and train CRAs and study sites on CRF completion and data entry.
• Maintain data management documentation for audits and regulatory inspections.
• Adhere to QMS and data privacy principles.

Kenntnisse

Analytical thinking

Organizational skills

Project management

Written/verbal communication

Ausbildung

Bachelor’s degree with 5+ years

Master’s degree (preferred)

Tools

iMedidata Rave

InForm

eClinicalOS

REDCap

Microsoft Office

Jobbeschreibung

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on developing innovative medical device therapies for severe conditions.

We are seeking a Temporary Clinical Data Manager (CDM) to dedicate 20 hours per week to support ongoing clinical study activities across the trial lifecycle. The Clinical Data Manager acts as the departmental subject matter expert (SME) and lead data manager across assigned projects, utilizing deep functional knowledge of clinical trial logistics, Quality Management Systems (QMS), and regulatory requirements to ensure absolute data integrity and quality.

Key Responsibilities

• Study Lifecycle Leadership: Independently lead and execute end-to-end data management activities across assigned clinical trials—spanning study startup, conduct, database lock, and study closeout.
• Multidisciplinary Leadership & SMEs: Serve as the Data Management SME on project teams, defining data deliverables, timeline expectations, and resource allocations.
• CRO & Vendor Oversight: Provide operational oversight for Data Management CROs and external vendors to ensure strict adherence to clinical protocols, Good Clinical Practices (GCPs), SOPs, and regulatory standards.
• Quality & Data Integrity: Collaborate closely with Biostatistics, Clinical Affairs, and Medical Affairs teams to monitor trial progress, track study metrics, and audit data accuracy.
• Site & CRA Training: Create training materials and train Clinical Research Associates (CRAs) and study sites on Case Report Form (CRF) completion and data entry consistency.
• Regulatory & Audit Readiness: Maintain data management documentation according to Penumbra and regulatory archiving standards; participate actively in regulatory audits and inspections.
• QMS & Compliance: Adhere to Penumbra’s Quality Management System (QMS), domestic/global quality system regulations, security, and data privacy principles.

Minimum Experience & Education

• Bachelor’s degree with 5+ years of clinical data management experience within a medical device company, pharmaceutical company, or Contract Research Organization (CRO) — OR an equivalent combination of education and experience.
• Must be legally eligible to live and work in the United States.

Technical Skills & Domain Expertise

• Strong, practical experience working with Electronic Data Capture (EDC) platforms (e.g., iMedidata Rave, InForm, eClinicalOS, REDCap).
• Demonstrated experience leading data management for regulatory clinical trials within the medical device or pharmaceutical industry.
• Thorough knowledge of Good Clinical Practices (GCPs) and global regulatory guidelines pertaining to clinical data quality.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Soft Skills

• Exceptional analytical, organizational, project management, and written/verbal communication skills.
• Ability to operate independently, manage changing project priorities, and maintain a service-oriented mindset across cross-functional teams.

Preferred Qualifications

• Master’s degree with 3+ years of clinical research experience in medical devices or pharmaceuticals.
• Certified Clinical Data Manager (CCDM) credential.
• Knowledge of continuous improvement, risk management, and formal change management frameworks.

Benefits & Total Rewards (Eligible Employees)

• Competitive hourly base pay ($50.00 – $80.00/hr based on experience and location).
• Comprehensive medical, dental, vision, life, short-term/long-term disability, and AD&D insurance.
• 401(k) retirement plan with company matching contributions.
• Paid time off (paid holidays, accrued vacation, paid sick leave, and parental leave).