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Associate Central Monitor, Data Surveillance, Clinical Data Sciences

0-2 years
Not Disclosed
10 Nov. 13, 2024
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

Role Summary:
As an Associate Central Monitor, you will support the completeness, quality, and integrity of clinical trial subject data under the Risk-Based Monitoring (RBM) approach. Key activities include developing RBM systems, ensuring key risk indicators (KRIs) are defined, and assisting in risk-based monitoring tasks while complying with relevant regulations and Standard Operating Procedures (SOPs). You will collaborate with the Senior Central Monitor (Sr. CM) to ensure study objectives are met.

Role Responsibilities:

General:

  • Implement global strategies and initiatives to ensure consistent, efficient, and quality processes.
  • Assist in setting up and testing the Risk-Based Monitoring system at the study level.
  • Execute communication plans and methods to meet study requirements.
  • Resolve conflicts and communicate with stakeholders effectively.

System Setup Functions:

  • Set up and test RBM system at study level to ensure system quality.
  • Define key risk indicators (KRIs) and ensure consistency between standard and study levels.
  • Ensure RBM system aligns with study protocol and adheres to ICH GCP, SOPs, corporate standards, and regulatory requirements.

Data Review Functions:

  • Maintain documentation related to Quality Control for RBM activities ensuring data completeness and accuracy.
  • Assist in central monitoring activities, including system reviews and signal management.

Basic Qualifications:

  • Bachelor’s degree in a scientific or business-related discipline.
  • 0-2 years of relevant work experience.
  • Ability to work independently and manage tasks, time, and priorities effectively.
  • Strong communication skills with internal and external stakeholders.

Preferred Qualifications:

  • Working knowledge of the clinical development process, including Phase I-IV trials and study design principles.
  • Technical expertise in clinical trial database development, data management, and site monitoring.
  • Previous experience in data management roles, including CRF design, database setup, and data cleaning.
  • Familiarity with clinical trial management processes and regulatory operations.
  • Knowledge of Windows applications (Word, Excel, PowerPoint, Project, etc.).
  • Experience in Oracle, PL/SQL, SAS, Java, and relational database design.

Why Pfizer?
At Pfizer, we are patient-centric and guided by our values: courage, joy, equity, and excellence. Join us in transforming the future of healthcare through our digital transformation strategy and dedication to breakthroughs that change lives.

Equal Employment Opportunity:
We value diversity and inclusion in our workforce. Pfizer is committed to creating an inclusive work environment, offering equal employment opportunities for all candidates.

Disability Inclusion:
We ensure equal opportunities for candidates with disabilities and encourage all to apply.

Your journey with Pfizer starts here!