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Clinical Data Manager Ii

5+ years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Data Manager II
Location: San Mateo, California (Remote)
Contract Duration: 12-month contract
Job Type: Full-time

Job Description:

The Clinical Data Manager II (CDM II) is responsible for overseeing data management across multiple studies within a CRO environment. Reporting to the Manager/Senior Manager, Clinical Data Management, the CDM II will be responsible for coordinating data management activities throughout study design, execution, data collection, and database lock. This role involves maintaining clinical studies and collaborating with internal teams, sponsors, and external vendors.

Key Responsibilities:

  • Vendor Collaboration:

    • Work closely with external vendors (e.g., safety labs, cardiac labs, IRT, ECG, ePRO/electronic diary providers) to create data transfer documents.

    • Reconcile third-party data with the clinical database to ensure accuracy.

  • Study Activity & Billing:

    • Understand and manage the study billing guide, forecasting available hours for study activities.

    • Ensure activities align with the study budget and promptly report any out-of-scope changes to the Senior CDM.

  • Time Tracking:

    • Regularly log time spent on project and non-project work using InClin’s time tracking tool (daily time entries preferred, weekly at a minimum).

Knowledge & Skill Requirements:

  • Experience:

    • 5+ years of progressive experience in Data Management.

    • Previous experience in a Contract Research Organization (CRO) environment is preferred.

  • Education:

    • B.S./B.A. in a science or technical discipline is preferred.

  • Other Skills:

    • Willingness to travel for clinical visits, face-to-face study team meetings, and Investigator Meetings as required.

How to Apply:

Click the Apply Now button to submit your application.