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Senior Associate Central Monitor, Risk-Based Monitoring

3-5 years
$78,000.00 to $130,000.00
10 Dec. 26, 2024
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

The Sr. Central Monitor at Pfizer plays a crucial role in ensuring the completeness, quality, and integrity of clinical trial data within Pfizer's Risk-Based Monitoring (RBM) ecosystem. This position involves developing, implementing, and overseeing risk-based monitoring strategies across clinical trials, ensuring compliance with regulatory requirements, and collaborating with study teams to manage issues and risks.

Role Responsibilities:

  1. Global Strategy and Implementation:

    • Develop and implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and high-quality monitoring processes.
    • Translate study risks into technical specifications to support the RBM approach.
    • Execute communication plans to ensure customer satisfaction and improvements during studies.
  2. System Setup and Oversight:

    • Review protocols to ensure that set-up, review, and reporting requirements are met.
    • Provide technical oversight and coordination for all central monitoring activities.
    • Define RBM system requirements, key risk indicators (KRIs), and ensure alignment with study objectives and regulatory standards.
  3. Data Review and Issue Management:

    • Work with study teams to define issue resolution for risk signals and actions.
    • Review system outputs, propose actions for signal and risk management, and follow up with teams for resolution.
    • Document lessons learned and share them with other teams to improve future studies.
  4. Quality Control and Monitoring:

    • Develop and maintain quality control documentation for RBM activities.
    • Ensure data completeness and accuracy throughout the study lifecycle.
    • Oversee risk-based monitoring systems, ensuring compliance with ICH GCP, SOPs, and regulatory standards.

Basic Qualifications:

  • Education: Bachelor’s degree or equivalent in a scientific or business-related discipline.
  • Experience: 3–5 years in clinical development, with a strong understanding of clinical trials, study design, and clinical database management.
  • Knowledge: Familiarity with clinical trial processes, data management, site monitoring, and external data flows.

Technical Skills:

  • Expertise in clinical trial support, data management, and project management.
  • Strong understanding of clinical study management and regulatory operations.
  • Proficient in using tools such as Microsoft Office Suite (Word, Excel, PowerPoint, Project).
  • Ability to communicate effectively with internal and external stakeholders, both locally and globally.

Physical/Mental Requirements:

  • Primarily office-based position, involving sitting, walking to meetings, and presenting.

Work Location: Remote/Hybrid

Salary & Benefits:

  • Salary Range: $78,000 to $130,000 annually, with a 10% bonus target.
  • Benefits: Includes 401(k) with Pfizer Matching Contributions, medical, dental, vision coverage, paid vacation, holiday, caregiver/parental leave, and more.

Sunshine Act Compliance:

Pfizer reports payments and other transfers of value to healthcare providers as required by transparency laws. This includes any recruitment-related expenses for licensed physicians.

EEO & Employment Eligibility:

Pfizer is an equal opportunity employer and complies with national, state, and local laws regarding nondiscrimination and work eligibility.

This position is ideal for a clinical trial professional with strong project management skills, a passion for quality monitoring, and the ability to work collaboratively across global teams to ensure clinical trial success.