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    Sr Site Manager

    Johnson & Johnson
    2+ years
    Not Disclosed
    Mumbai
    10 Nov. 7, 2024
    Job Description
    Job Type: Full Time Education: B.Sc/ M.Sc/ B.E/ M.E./ B.Com/ M.Com/ BBA/ MBA/B.Tech/ M.Tech/ All Graduates 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

    Sure! Here's the rewritten job description for the Senior Site Manager role with an optimized slug for better SEO and URL purposes:

    Senior Site Manager - Clinical Trial Support

    Location: Mumbai, Maharashtra, India
    Function: R&D Operations
    Category: Experienced Analyst, Clinical Trial Support (P5)
    Date Posted: Oct 29, 2024
    Requisition Number: 2406219586W

    Position Summary:

    The Senior Site Manager is a mid-level role typically requiring 3-5 years of experience in clinical trial management. This role acts as the primary contact point between the Sponsor and Investigational Sites, ensuring compliance with clinical trial protocols, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and relevant regulatory guidelines. Responsibilities include overseeing site initiation, monitoring (both remote and on-site), managing recruitment and retention strategies, and supporting site closure activities. The Senior Site Manager works closely with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) to ensure the successful execution of trials. This role is expected to operate independently, with minimal supervision, and may include mentoring junior staff and leading process improvement initiatives.

    Principal Responsibilities:

    • Serve as the primary local company contact for assigned sites throughout the trial.
    • Actively participate in site feasibility assessments and Site Qualification Visits.
    • Attend and present at investigator meetings as needed, and assist in preparation of meeting materials.
    • Oversee site initiation, start-up, monitoring, and close-out activities in accordance with SOPs and policies.
    • Ensure the implementation of a risk-based monitoring model at the site level and work with sites to resolve issues promptly.
    • Ensure proper training of site staff and that training records are accurate and up-to-date at all times.
    • Collaborate with the Local Trial Manager (LTM) and central study teams to accelerate site activation.
    • Contribute to site recruitment strategies and contingency planning in partnership with other functional teams.
    • Manage site study supplies (Non-Investigational Product (IP), lab kits, etc.), ensuring adequate stock levels and proper storage and handling of clinical supplies.
    • Ensure timely and accurate data entry by site staff and resolve queries within expected timelines.
    • Ensure the validity, accuracy, and completeness of data collected from trial sites.
    • Monitor and ensure all Adverse Events (AEs), Serious Adverse Events (SAEs), and Product Quality Complaints (PQCs) are reported and documented according to timelines.
    • Maintain accurate documentation of all trial-related activities, including visit reports and follow-up communications.
    • Review study files for completeness and ensure proper archiving of essential documents.
    • Communicate site/study progress and issues to the central trial team in collaboration with the LTM.
    • Participate in team meetings and training, contributing feedback as necessary.
    • Ensure Corrective and Preventative Actions (CAPA) are taken for quality issues identified during audits or monitoring visits.
    • Prepare sites for close-out and conduct final close-out visits.
    • Track site-related costs and ensure timely payments, if applicable.
    • Build and maintain strong working relationships with internal and external stakeholders, especially site investigators and coordinators.
    • May participate in Health Authority (HA) and IEC/IRB submission and notification processes.
    • Act as a point of contact for site management and offer expert input as needed.
    • Potential to mentor junior Site Managers and contribute to process improvements.

    Principal Relationships:

    • Primary Reporting Structure: Reports to FM/CRM.
    • Key Interfaces: LTM, TDL, CTA, and FM/CRM teams.
    • Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Compliance Managers/Specialists, Training Manager, Contracts & Centralized Services (CCS), Local Safety Officer, and Site Manager team.
    • External Interfaces: Investigators and their delegates at site (trial site personnel).

    Qualifications:

    • Required: BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience).
    • Experience: A minimum of 2 years of clinical trial monitoring experience is required. 3-5 years of experience is preferred.
    • Preferred: Specific therapeutic area experience may be required, depending on the position.
    • Skills:
      • Strong knowledge of GCP, SOPs, local laws, and regulations.
      • Proficiency in clinical trial management systems and software.
      • Willingness to travel and stay overnight occasionally.
      • Strong communication skills in both English and the local language.
      • Ability to manage multiple trials simultaneously.
      • Excellent problem-solving capabilities and demonstrated ability to deliver successful trials.
      • Ability to communicate effectively and engage with site personnel.

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