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Senior Clinical Data Manager

6-8 years
$165,000 – $205,000 per year
10 May 1, 2025
Job Description
Job Type: Hybrid Education: MS/MBA 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: Senior Clinical Data Manager / Associate Director, Clinical Data Management

Location: South San Francisco, CA (Hybrid)
Company: Confidential (via Meet Life Sciences)
Employment Type: Full-time
Salary: $165,000 – $205,000 per year
Industry: Biotechnology / Clinical Research / Data Management


Company Overview

An innovative biotech company is hiring a Senior Clinical Data Manager to support its growing portfolio of clinical trials. The role offers an exciting opportunity to work in a dynamic environment and lead data management efforts across early- and late-phase clinical studies.


Position Summary

The Senior Clinical Data Manager (or Associate Director, depending on experience) will be responsible for leading and managing clinical data activities across multiple studies. The role involves cross-functional collaboration, vendor oversight, data quality assurance, and adherence to regulatory and CDISC standards.


Key Responsibilities

  • Lead data management activities for multiple clinical studies (Phases I–IV).

  • Serve as the primary CDM contact for internal teams and vendors.

  • Develop and review CRFs, data validation plans, edit checks, and eCRF specifications.

  • Oversee database builds and conduct UAT for data integrations and CRFs.

  • Ensure timely and accurate data transfers, reviews, and database locks.

  • Review protocols, statistical analysis plans, and TFL outputs.

  • Manage CRO/vendor performance and participate in RFP/vendor selection.

  • Maintain inspection-ready documentation and ensure regulatory compliance.

  • Drive initiatives to improve processes and data quality systems.


Required Qualifications

  • Bachelor’s degree in life sciences or related field (MS/MBA preferred).

  • 6–8+ years of clinical data management experience in biotech/pharma.

  • Experience with EDC systems, CDISC (SDTM/ADaM), SAS, and SQL.

  • Familiarity with MedDRA and WHO Drug coding.

  • Strong knowledge of ICH GCP, FDA CFR, and other clinical data regulations.

  • Rare disease trial experience is a plus.

  • Proven leadership in cross-functional team settings.

  • Strong communication, organizational, and vendor management skills.