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    Manager, Clinical Data Scientist, Clinical Data Sciences

    Pfizer
    5+ years
    $99,900.00 to $166,500.00
    Collegeville Groton New York
    10 Dec. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Why Patients Need You

    Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidence-based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating frameworks to ensure the scientific soundness of our evidence, providing unbiased, medically necessary expertise, or investigating ways to close gaps in data, our mission is simple: Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

    What You Will Achieve

    As part of our mission to strengthen the oversight of clinical data, you will play a critical role in processing, reviewing, and receiving patient data and records. You will organize clinical data forms from therapeutic groups and external investigators, ensuring that accurate, timely, and consistent clinical data reaches the medical department and other groups.

    Your responsibilities will include:

    • Data Management: Managing data preparation and validation activities, ensuring accurate and timely clinical data.
    • Leadership: Provide guidance and lead/co-lead projects, manage time effectively to meet objectives, and plan resources across the division.
    • Operational Excellence: Ensure the work carried out by providers aligns with Standard Operating Procedures (SOPs) and working practices.
    • Collaboration: Work as a Clinical Data Scientist and Trial Lead, managing all Data Monitoring and Management (DMM) activities, and collaborating with study teams.
    • Communication: Plan and execute communication plans for engaging customer populations and ensure efficient data management.

    How You Will Achieve It

    • Project Management: Lead/co-lead projects, plan resource requirements, and guide teams toward operational excellence in data management.
    • Operational Guidance: Ensure compliance with regulatory requirements, SOPs, and best practices in clinical data management.
    • Collaboration with External Partners: Partner with Research/Business Units and external Data Management service providers to deliver high-quality data.
    • Data Monitoring: Conduct central monitoring activities, propose suggestions for signal and action management, and follow up on resolutions with study teams.

    Qualifications

    Must-Have

    • Bachelor’s Degree in a relevant field.
    • 5+ years of experience in the pharmaceutical industry or in a health information management role.
    • Clinical Trial Knowledge: Working knowledge of all phases of clinical trials and experience in protocol review.
    • Regulatory Knowledge: Knowledge of clinical research, FDA regulations, and International Conference on Harmonization (ICH) Good Clinical Practices (GCP).
    • Project and Risk Management: Experience in managing clinical data projects and risks.
    • Communication Skills: Strong verbal and written communication skills, with the ability to manage multiple tasks and projects.
    • Technical Skills: Proficiency in Windows Environment and related applications.

    Nice-to-Have

    • Master's Degree in a relevant field.
    • CRO Experience: Experience overseeing Contract Research Organizations (CROs) and vendors.
    • Clinical Data Management Systems: Proficiency in using commercial clinical data management systems or EDC products.

    Other Job Details

    • Last Date to Apply for Job: 26 December 2024
    • Eligible for Employee Referral Bonus: Yes
    • Not Eligible for Relocation Assistance: Yes
    • Work Location: Flexible. Colleagues are assigned a Pfizer site within a commutable distance and are expected to work 2-3 days a week onsite with flexibility for remote work.

    Compensation and Benefits:

    • Annual Salary Range: $99,900.00 - $166,500.00
    • Bonus: Eligible for Pfizer’s Global Performance Plan (15% bonus target)
    • Additional Benefits: 401(k) plan with Pfizer matching contributions, paid vacation, health coverage, paid leave, and more.

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. This position requires permanent work authorization in the United States.

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