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    Associate Site Manager

    Johnson & Johnson
    1+ years
    Not Disclosed
    Mumbai
    10 Nov. 7, 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

    Associate Site Manager - Clinical Trial Support

    Location: Mumbai, Maharashtra, India
    Function: R&D Operations
    Category: Analyst, Clinical Trial Support (P4 - E24)
    Date Posted: Nov 04, 2024
    Requisition Number: 2406219587W

    Position Summary:

    The Associate Site Manager is an entry-level role within clinical trial management, typically requiring 0-2 years of experience. This role acts as the primary point of contact between the Sponsor and the Investigational Site, ensuring compliance with the clinical trial protocol, company SOPs, Good Clinical Practice (GCP), and relevant regulations from study start-up to site closure. Responsibilities include assisting with site selection, subject recruitment, on-site and remote monitoring, and site closure activities. The Associate Site Manager will work closely with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) to manage trial sites and ensure smooth execution of the study.

    Principal Responsibilities:

    • Serve as the primary contact for assigned sites and provide support for trial activities from initiation to close-out.
    • Participate in site feasibility and qualification assessments as needed.
    • Assist in executing site initiation and start-up activities, including site monitoring, both remote and on-site.
    • Ensure compliance with GCP, SOPs, and relevant regulations during trial execution.
    • Support the recruitment strategy and contingency planning for site-level activities.
    • Ensure site staff are properly trained, with accurate and up-to-date training records.
    • Manage site supplies, including clinical drug and non-investigational products, and ensure proper documentation of their use and storage.
    • Track study-related data entry and query resolution, ensuring data accuracy and completeness.
    • Ensure timely reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), and Product Quality Complaints (PQCs) in accordance with required timelines.
    • Support Corrective and Preventative Actions (CAPA) for any quality issues identified during routine monitoring or audits.
    • Collaborate with the Local Trial Manager (LTM) and study central team to communicate site progress and issues.
    • Participate in site close-out activities and ensure compliance with archiving and retention requirements.

    Principal Relationships:

    • Primary Reporting Structure: Reports to FM/CRM.
    • Key Interfaces: LTM, TDL, CTA, and FM/CRM teams.
    • External Interfaces: Investigators and trial site personnel.

    Qualifications:

    • Required: BA or BS degree in Pharmacy, Nursing, Life Sciences, or a related scientific field (or equivalent experience).
    • Experience: A minimum of 1 year of clinical trial monitoring experience (1-2 years preferred).
    • Skills:
      • Basic understanding of GCP, SOPs, and clinical trial monitoring procedures.
      • Proficiency in relevant IT systems and software.
      • Ability to travel occasionally, including overnight stays.
      • Strong communication skills, both verbal and written, in English and local language.

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