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    Sr. Clinical Study Associate

    Daiichi-Sankyo
    2+ years
    Not Disclosed
    15 June 12, 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, 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 Description: Study Associate Manager (Clinical Operations)

    Company Information

    Employer: Daiichi Sankyo, Inc.
    Category: Clinical Research
    Job Type: Full Time
    Location: Basking Ridge, New Jersey (NJ), United States
    Job Code: J3T0G16RVTV9FZ4WZSD
    Post Date: 06/06/2024

    Company Description

    Daiichi Sankyo Group is a global pharmaceutical company with over 100 years of scientific expertise. The company focuses on innovative pharmaceutical therapies to improve standards of care and address unmet medical needs. With a presence in more than 20 countries and 16,000 employees worldwide, Daiichi Sankyo aims to become a "Global Pharma Innovator with Competitive Advantage in Oncology" by 2025. The company's research areas also include rare diseases and immune disorders.

    Job Summary

    The Study Associate Manager assists in planning and executing clinical studies under the supervision of the Study Manager within Clinical Operations. This role involves ensuring adherence to protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The key focus is on providing clinical trial management support and tracking CRO and vendor performance against project goals.

    Responsibilities

    • Document Management:
      • Reconcile TMF document trackers generated by the CRO with the document archive.
      • Distribute key study documents to the CRO and vendors.
    • Administrative Support:
      • Provide clinical administrative support, including preparing meeting logistics, distributing agendas, and minutes for various meetings.
    • Budget Evaluation:
      • Support Fair Market Value process in evaluating study budgets.
    • Regulatory Coordination:
      • Collect information and coordinate with Regulatory Operations to post trial information on public forums (e.g., clinicaltrials.gov).
    • Report Review:
      • Under supervision, review CRO-generated reports and elevate issues to the supervisor.
    • Metrics and Tracking:
      • Analyze study site metrics reports to identify areas of concern.
      • Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, and TMF filing.
      • Create and maintain tracking spreadsheets for various items (e.g., vendor invoices).
    • Insurance and Vendor Oversight:
      • Work with Insurance Brokers to obtain study site insurance.
      • Provide tracking and oversight to vendors handling lab logistics and other tasks.
    • Training and Development:
      • Participate in training and recommend areas for improvement and innovation.
      • Work with supervisor to develop an individual career development plan.

    Qualifications

    • Education:
      • Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience.
    • Experience:
      • 2 or more years of relevant experience in clinical or basic research within a Pharmaceutical company, Medical device/Diagnostic company, Academic Research Organization (ARO), or Contract Research Organization (CRO).
      • CRA experience and time spent directly in a medical environment (e.g., as a Study Site Coordinator) preferred.
    • Travel:
      • Ability to travel up to 5%. This is primarily an in-house office position that may require occasional travel.

    Additional Information

    Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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