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Senior Associate, Data Manager, Clinical Data Sciences

3+ years
Not Disclosed
10 Dec. 20, 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 Title: Senior Associate, Data Management
Location: [Insert Location]
Category: Medical
Job ID: [Insert Job ID]

Why Patients Need You
Pfizer's Worldwide Medical and Safety team plays a pivotal role in connecting evidence-based medical decision support with colleagues and stakeholders to improve health and treatment outcomes. Whether it's ensuring scientifically sound evidence, offering unbiased medical expertise, or closing gaps in data, our mission remains clear: empower healthcare decisions that ensure the safe and appropriate use of medicines for patients.

What You Will Achieve
You will contribute significantly to strengthening the oversight of clinical data through better ownership, control, and visibility. As a Senior Associate, you will manage the processing, reviewing, and receiving of clinical data from therapeutic groups, investigators, and teams. Your efforts will ensure accurate, timely, and consistent data reaches clinical teams and other key stakeholders. You will take ownership of data management plans, including data preparation, validation activities, and ensuring operational excellence in collaboration with cross-functional teams.

Key Responsibilities:

  • Manage own time to meet agreed targets and develop work plans for activities related to clinical trials.
  • Serve as Data Manager for one or more clinical trials, overseeing Data Monitoring and Management (DMM) activities.
  • Collaborate with partners and colleagues for application of standards and develop data cleaning reports in support of data review plans.
  • Ensure operational excellence across all DMM deliverables, including setting up and testing data review listings to ensure data quality and completeness.
  • Document and share lessons learned across study teams to facilitate cross-study learning.
  • Build and maintain strong relationships with local and global subject matter experts (SMEs) from various fields, leveraging their expertise to proactively address issues and implement solutions.

Qualifications:
Must-Have:

  • Bachelor's Degree
  • 3+ years of experience in data management
  • Strong understanding of data management processes and principles
  • Experience with web-based data management systems
  • Knowledge of electronic document management systems
  • Familiarity with International Conference on Harmonization (ICH) guidelines and Good Clinical Practices (GCP)
  • Thorough understanding of clinical study management processes and regulatory operations
  • Ability to manage tasks, prioritize, and handle time effectively
  • Effective verbal and written communication skills, with the ability to tailor communication to different audiences

Nice-to-Have:

  • Master’s degree
  • Relevant pharmaceutical industry experience
  • Experience with data visualization tools
  • Proficient in using commercial clinical data management systems or EDC products
  • Awareness of regulatory requirements and data standards

Work Location: On-Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.