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Manager, Clinical Data Scientist, Clinical Data Sciences

5+ 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: Manager, Clinical 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 key role in ensuring the safe and appropriate use of medicines by providing evidence-based medical decision support. Whether it's creating frameworks to ensure scientifically sound evidence, offering unbiased medical expertise, or addressing gaps in data, our mission is clear: empower healthcare decisions to improve treatment outcomes for patients globally.

What You Will Achieve
Your role will be vital in strengthening the oversight and management of clinical data through improved ownership, control, and visibility. You will handle processing, reviewing, and organizing patient data and clinical records from therapeutic groups and external investigators. Your responsibility will be to ensure that accurate, timely, and consistent data reaches relevant medical departments and stakeholders. You will contribute to data management plans, including data preparation and validation activities, while also guiding teams and improving processes.

As a Manager, you will lead projects, forecast resource needs, and identify areas for product, process, or service improvements. Your leadership and planning skills will be crucial in achieving new milestones and ensuring the success of clinical trials. Your contributions will directly impact Pfizer’s ability to improve health outcomes worldwide.

Key Responsibilities:

  • Lead and co-lead clinical data management projects, planning resource requirements and managing timelines for successful project execution.
  • Ensure compliance with Standard Operating Procedures (SOPs) and industry best practices in clinical data management.
  • Promote efficient, high-quality processes to meet deliverables and timelines.
  • Serve as the Clinical Data Scientist and Trial Lead for multiple clinical trials, overseeing all Data Monitoring and Management (DMM) activities.
  • Act as a technical resource for study teams, providing expertise in data visualization, reporting tools, and technology systems.
  • Ensure operational excellence through collaboration with partners for data acquisition, proactive data review, and data integrity.
  • Collaborate with Research/Business Units and external service providers to deliver high-quality data management across studies.
  • Perform central monitoring activities, proposing action plans based on system outputs and ensuring resolutions.
  • Develop and execute communication strategies to engage with customer populations effectively.

Qualifications:
Must-Have:

  • Bachelor's Degree
  • 5+ years of experience in clinical data management or a related field within the pharmaceutical industry
  • In-depth knowledge of clinical trial phases and ability to assess study requirements from protocol review
  • Familiarity with clinical research regulations, including FDA and ICH GCP guidelines
  • Strong project and risk management skills
  • Excellent verbal and written communication abilities, with the capability to handle multiple tasks and projects
  • Proficiency with Windows operating systems and relevant applications

Nice-to-Have:

  • Master's degree
  • Experience in Contract Research Organization (CRO) oversight and vendor management
  • Expertise in using commercial clinical data management systems or EDC tools

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.