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    Senior Project Manager

    Lambda Therapeutic Research
    8-10 years
    Not Disclosed
    Ahmedabad
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: MSc/Mpharm/Bpharm/BAMS/BHMS 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: Senior Project Manager
    Company: Lambda Therapeutic Research Ltd.
    Location: Ahmedabad, India
    Date: December 26, 2024

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations across India, the USA, Canada, Poland, and the UK, Lambda provides end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

    Job Description

    Lambda Therapeutic Research Ltd. is seeking a Senior Project Manager for its clinical trial start-up division. This role will be responsible for overseeing the start-up activities of clinical trials, including site identification, budgeting, coordination with various stakeholders, and ensuring regulatory compliance. The Senior Project Manager will work closely with the Start-Up Lead, CTM Lead, and other teams to ensure smooth execution of clinical trial initiation and site management.

    Key Responsibilities

    • Study Start-up Coordination:

      • Coordinate with the Start-Up Lead, CTM Lead, and PMs for site identification for awarded studies.
      • Prepare investigator site budgets and finalize them in consultation with the Start-Up Lead and CTM Lead.
      • Ensure executed MSA/quotes are updated in the CTMS before initiating study-related activities.
      • Finalize feasibility questionnaires for specific studies in consultation with the CTM Lead and Medical Monitor.

    • Site Finalization and Vendor Coordination:

      • Finalize sites for feasibility questionnaire collection and ensure necessary study-specific templates (e.g., IU, PSP, FDA forms) are reviewed and finalized.
      • Coordinate with vendors to ensure the availability of study instruments before site initiation.

    • Regulatory and Site Coordination:

      • Support the regulatory team in completing the DCGI dossier and resolving any queries from the Regulatory Authority team.
      • Negotiate site budgets and ensure CTA execution in line with the sponsor’s MSA.
      • Coordinate with sites for EC (Ethics Committee) related activities.

    • Project Management and Oversight:

      • Ensure the CTMS is regularly updated with new investigators and sites.
      • Review IMP (Investigational Medicinal Product) release and ensure SIV (Site Initiation Visit) clearance before execution.
      • Coordinate with vendors and internal stakeholders for all start-up activities.
      • Assist with any other responsibilities as assigned by Management or the Head of Department (HOD).

    Key Deliverables

    • Finalized feasibility questionnaires for studies.
    • Identification and selection of clinical trial sites.
    • Successful initiation of clinical studies.
    • Finalization and negotiation of site budgets.
    • Coordination with stakeholders for site initiation.

    Experience

    • At least 8-10 years of experience in clinical trials, preferably within the start-up division.

    Educational Qualification

    • Required: MSc, MPharm, BPharm, BAMS, BHMS, Dentist, or similar medical science background.

    Competencies

    • Accountability: Strong responsibility for the project's success.
    • Communication: Effective communication skills with internal and external stakeholders.
    • Work Ethic: High commitment to deadlines and quality.
    • Initiative: Proactive approach in managing project tasks.
    • Leadership: Ability to lead teams and guide project activities.
    • Technical Knowledge: Understanding of clinical trials, regulations, and start-up processes.
    • Motivation/Initiative: Strong motivation to drive project progress.
    • Interpersonal Skills: Effective teamwork and interpersonal communication.
    • Flexibility/Planning & Organizing: Ability to prioritize and manage multiple tasks efficiently.

    How to Apply

    Interested candidates can apply through Lambda Therapeutic Research Ltd.'s official career portal.

    Let me know if you need more information or assistance!

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