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​​Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences​

5+ 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

Job Opportunity: Central Monitor (Risk-Based Monitoring) at Pfizer

Location: Hybrid
Role Summary:
The Central Monitor is responsible for ensuring the completeness, quality, and integrity of clinical trial subject data under Risk-Based Monitoring (RBM). This includes developing RBM systems, defining key risk indicators (KRIs), reviewing study data for signal and action management, and troubleshooting database issues. The role ensures compliance with regulations, Standard Operating Procedures (SOPs), and protocols, and collaborates with the global study team to achieve study objectives.

Role Responsibilities:

General:

  • Implement global strategies and standards to ensure quality, efficiency, and timely deliverables.
  • Provide technical expertise to set up and test the RBM system at the study level.
  • Review study-level system outputs to manage signals and actions.
  • Execute communication plans to ensure customer satisfaction and continuous improvements.
  • Provide technical support to resolve conflicts and communicate with stakeholders.

System Setup Functions:

  • Set up and test RBM systems to ensure study quality.
  • Define KRIs and ensure consistency between standard and study-level setups.
  • Ensure alignment of RBM systems with protocol requirements and regulatory standards (ICH GCP, SOPs).

Data Review Functions:

  • Define resolutions for issues identified in data reviews.
  • Implement and maintain documentation for RBM activities to ensure data completeness and accuracy.
  • Perform central monitoring tasks, including reviewing system outputs and managing signal resolutions.
  • Collaborate with Clinical Data Scientists (CDS) to ensure proper mitigation of signals and actions.

Basic Qualifications:

  • Bachelor’s degree (or equivalent) in a scientific or business-related discipline.
  • Minimum of 3 years of experience in clinical trial-related roles (CRA, DM, Programmer, etc.).
  • Expertise in supporting clinical trials database development, data management, and site monitoring.
  • Proficiency in clinical study management, data management, and regulatory operations.
  • Strong communication skills (verbal and written), with the ability to work independently and prioritize tasks.

Preferred Qualifications:

  • Knowledge of clinical development processes, Phase I-IV concepts, and study design principles.
  • Experience with CRF design, database setup, edit check specifications, DMPs, and data cleaning.
  • Familiarity with clinical trial databases and applications.
  • Proficiency in Windows applications (Word, Excel, PowerPoint, Project).
  • Experience with Oracle, PL/SQL, SAS, Java, and database programming.

Work Location Assignment: Hybrid

To Apply:
Send your CV and motivational letter in English.

Why Pfizer?
At Pfizer, we're dedicated to breakthrough innovations that change lives. We foster a patient-centric culture and embrace values such as courage, joy, equity, and excellence. Join us as we lead in digital transformation to accelerate drug discovery and development.

Flexibility:
We aim to provide a flexible, trusting workplace culture, enabling employees to achieve work-life harmony and thrive.

Equal Employment Opportunity:
Pfizer celebrates diversity and is committed to creating an inclusive workforce. We ensure equal opportunities for all, empowering employees to succeed.

Disability Inclusion:
We are a disability-inclusive employer, offering support and accommodations for all candidates. Let us help you succeed with reasonable adjustments for your application and career.

Your journey with Pfizer starts here!