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    Manager, Study Associates

    Daiichi-Sankyo
    1-4 years
    Not Disclosed
    Basking Ridge
    10 July 10, 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

    Position Information:

    • Title: Manager, Study Associates
    • Company: Daiichi Sankyo, Inc.
    • Department: Clinical Research
    • Job Type: Full Time
    • Job Code: J3N1VS76BT0ZR6NL6CZ
    • Location: Basking Ridge, New Jersey, United States
    • Post Date: 06/28/2024

    Company Overview:

    Daiichi Sankyo Group has over 110 years of scientific expertise and operates in more than 20 countries. With a focus on oncology, rare diseases, and immune disorders, the company aims to address unmet medical needs through innovative pharmaceutical therapies. Under its 2025 Vision, Daiichi Sankyo aspires to be a "Global Pharma Innovator with Competitive Advantage in Oncology."

    Position Summary:

    The Manager, Study Associates will supervise a team of Study Associates (SAs) or Senior SAs under the guidance of the Associate Director. This role involves overseeing the planning and execution of clinical studies in compliance with protocols, GCPs, SOPs, FDA regulations/EU Directive, and ICH guidelines. The Manager will ensure that SAs provide clinical administrative support to study teams, monitor compliance with Quality Oversight measures, and manage staff training and performance.

    Key Responsibilities:

    1. Team Supervision:

      • Supervise a team of 10-12 Study Associates.
      • Participate in resume review, interviewing, hiring, and onboarding of new staff.

    2. Vendor Oversight:

      • Meet with contract agencies monthly to provide performance feedback, discuss contract statuses, and project timelines for current and future contract needs.

    3. Performance Management:

      • Evaluate employee performance through study team feedback and established performance metrics.
      • Provide feedback through regularly scheduled 1:1 meetings.
      • Collaborate with the Clinical Study Manager on SA deliverables.

    4. Process Improvement:

      • Participate in departmental and cross-functional process improvement initiatives as required.

    Qualifications:

    1. Education:

      • Bachelor's Degree required.
      • Master's Degree preferred.

    2. Experience:

      • 4+ years of relevant experience with a BS degree.
      • 1+ year of relevant experience with an MS degree.
      • Relevant experience includes clinical or basic research in a Pharmaceutical company, Medical device/Diagnostic company, ARO, or CRO.
      • CRA experience preferred.

    3. Physical Requirements:

      • In-house office position that may require occasional travel (10% of time).

    Equal Opportunity Employer:

    Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment 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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