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Senior Clinical Data Manager

6+ years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Senior Clinical Data Manager – Remote (USA or Canada)

Location: United States or Canada (Remote)
Company: ICON Strategic Solutions
Department: Clinical Data Management
Job ID: 2025-120902


Job Summary

ICON plc, the world's largest and most comprehensive healthcare intelligence and clinical research organization, is seeking a Senior Clinical Data Manager (CDM). This fully remote role is ideal for experienced professionals ready to lead data management operations across high-impact global clinical studies. Work on oncology, neuroscience, rare diseases, and more, while collaborating with cross-functional teams and regulatory bodies.


Key Responsibilities

  • Manage and coordinate clinical data management (CDM) process initiatives

  • Act as primary contact on CDM processes during study start-up, conduct, and close-out

  • Support CDM operations on eClinical tools including EDC and local lab setup

  • Communicate updates, training alerts, and process changes to CDM teams

  • Maintain SharePoint portals, trackers, and SOP documentation

  • Assist in Quality Assurance audits and inspections (FDA, EMA, etc.)

  • Ensure compliance with ICH-GCP, regulatory guidelines, and SOPs

  • Contribute to developing and revising CDM workflows for internal and outsourced studies


Required Skills & Qualifications

  • Minimum 6 years of experience in clinical data management or drug development

  • Proven project management in large-scale data programs

  • Expertise in ICH-GCP, FDA regulations, and global clinical trial processes

  • Strong understanding of clinical documents (protocols, SAPs, CRFs, study reports)

  • Experience handling regulatory inspections (FDA, EMA preferred)

  • Familiarity with clinical systems (EDC, SharePoint, LMS, etc.)

  • Ability to manage multiple projects simultaneously

  • Therapeutic area experience in oncology, GI, neuroscience, cell therapy, or rare diseases


Perks & Benefits

  • Competitive salary (not disclosed)

  • Generous paid leave policies

  • Comprehensive health insurance for employee & family

  • Retirement savings plans and pension support

  • Global Employee Assistance Programme (TELUS Health)

  • Life assurance and flexible benefits (e.g., gym, transport, childcare, health assessments)


About ICON Strategic Solutions

ICON is a global leader in clinical research and pharmaceutical development. With an unmatched healthcare intelligence platform, ICON supports top pharma and biotech companies in accelerating drug development through data-driven innovation and regulatory excellence.


Work Mode

Remote – Available across the United States and Canada


Call to Action

Ready to advance your career in global clinical data management? Apply now and join ICON to shape the future of drug development and healthcare outcomes.