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Senior Associate Central Monitor, Risk-Based Monitoring

3-5 years
$78,000.00 to $130,000.00
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/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

Role Summary:

The Senior Central Monitor at Pfizer will oversee and ensure the completeness, quality, and integrity of clinical trial data within Pfizer’s Risk-Based Monitoring (RBM) ecosystem. This includes developing and implementing monitoring strategies, managing key risk indicators (KRIs), processing and reviewing study data for risk signals, and resolving issues within clinical trials. The role serves as a liaison between the technical team and study teams, ensuring alignment between risk-based approaches and the clinical trial processes.

Responsibilities:

1. Strategic Oversight & Implementation:

  • Implement global strategies, initiatives, and processes to ensure consistency and efficiency in clinical trial monitoring.
  • Translate study risks into technical specifications for risk-based monitoring approaches.
  • Review RBQM (Risk-Based Quality Management) system outputs to analyze operational and data risks.
  • Develop communication plans to ensure customer satisfaction and promote improvements throughout the study.

2. System Setup Functions:

  • Review protocols to ensure RBM system set-up aligns with reporting requirements.
  • Provide guidance and oversight for central monitoring activities.
  • Define system requirements at the study level to support quality and study objectives.
  • Set up study-specific KRIs and ensure they align with protocols, ICH GCP, SOPs, and regulatory requirements.

3. Data Review Functions:

  • Collaborate with study teams to define issue resolution for identified risks.
  • Develop and maintain documentation related to RBM activities to ensure data completeness.
  • Perform central monitoring tasks, propose action plans for signal management, and follow up with the study team to resolve issues.
  • Work with Clinical Data Scientists to mitigate risks and ensure proper release of RBM systems.
  • Document lessons learned during the study and share them with other study teams for cross-study learning.

Basic Qualifications:

  • Education: Bachelor’s degree or equivalent in a scientific or business-related discipline.
  • Experience: 3-5 years of experience in clinical development, including familiarity with the clinical trial process and understanding of Phase I-IV studies.
  • Knowledge:
    • Clinical trial databases and data flow.
    • Clinical development processes and principles.
    • Site monitoring activities and database setup.

Technical Skills:

  • Expertise in clinical trials, data management, and site monitoring.
  • Project Management: Strong skills in managing timelines, deliverables, and resources.
  • Communication: Ability to communicate complex data and operational issues effectively with internal and external stakeholders.
  • Technology: Familiarity with advanced technologies used in clinical trials, including systems for RBM.

Physical/Mental Requirements:

  • Environment: Primarily office-based, with activities including meetings, presentations, and reporting.
  • Work Location: Remote/Hybrid.

Compensation & Benefits:

  • Salary: $78,000 to $130,000 per year.
  • Bonus: Eligible for a 10% performance-based bonus.
  • Benefits: Includes 401(k) with Pfizer Matching Contributions, health benefits (medical, dental, vision), paid time off, caregiver/parental leave, and more.

Application Details:

  • Last Date to Apply: January 7, 2024.
  • Relocation Assistance: May be available based on business needs.
  • Sunshine Act: Pfizer complies with transparency laws related to payments made to healthcare providers.

EEO & Employment Eligibility:

  • Pfizer is an equal opportunity employer, and this position requires permanent work authorization in the United States.

This position is an excellent opportunity for someone with experience in clinical trial monitoring, risk-based management, and project oversight to contribute to the success of Pfizer’s clinical trials.