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    Senior Project Manager

    Lambda Therapeutic Research
    0-2 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 27, 2024

    Job Description

    Lambda Therapeutic Research Ltd. is looking for a Senior Project Manager to manage and lead clinical trial projects, ensuring they are completed on time, within budget, and according to specified deliverables. The role will involve planning, coordinating regulatory submissions, budget management, and providing oversight to the clinical trial teams (CTA's/CRA's). The Senior Project Manager will also be responsible for project milestones, feasibility studies, quality control, and communication with stakeholders to ensure project success.

    Key Responsibilities

    • Project Planning and Management:

      • Develop detailed project plans, including timelines, budgets, and deliverables.
      • Ensure assigned projects are completed in a qualitative, cost-effective, and timely manner.
      • Track project milestones, timelines, and budgets, ensuring alignment with project goals.

    • Feasibility and Regulatory Coordination:

      • Conduct feasibility studies for clinical trials.
      • Coordinate regulatory submissions and ensure necessary approvals for study conduct, including CTRI registration.

    • Clinical Trial Coordination:

      • Allocate CTA’s/CRA’s to specific clinical trial projects.
      • Oversee system enhancements, including the development of study tools and tracking systems.
      • Assist new CRAs in developing and identifying investigators for assigned studies.
      • Plan and conduct clinical trial projects in collaboration with CTA’s/CRA’s and interdepartmental teams.
      • Assist in selecting study sites in conjunction with sponsors and Lambda teams, and recommend site assignments.

    • Training and Supervision:

      • Provide protocol-specific training to CTA’s/CRA’s, including study procedures, CRF conventions, SOPs, and therapeutic expertise.
      • Supervise activities of CTA’s/CRA’s, ensuring accuracy and completeness of monitoring visit reports and timely execution of project tasks.

    • Quality Control and Monitoring:

      • Conduct quality control and co-monitoring visits with CRA’s to ensure adherence to SOPs, GCP, and project requirements.
      • Guide CRA’s through pre-study, initiation, interim, and close-out monitoring visits as needed.

    • Financial and Reporting Oversight:

      • Review and approve payments to study sites and vendors.
      • Prepare reports and updates for sponsors, ensuring clear and accurate communication.

    • Stakeholder Communication:

      • Ensure effective communication between all project team members and stakeholders.

    • Software Development and Site Management:

      • Guide the software team in developing e-CRFs.
      • Identify and screen new sites and Principal Investigators (PIs).
      • Build and maintain a database of new PIs and study sites.

    • Continuous Improvement:

      • Identify areas for improvement in project management and suggest actionable strategies.

    Key Deliverables

    • Timely and budget-compliant completion of clinical trial projects.
    • Completed feasibility studies and regulatory submissions.
    • High-quality clinical trial execution with accurate monitoring and reporting.
    • Successful training and support for CRAs/CTAs.
    • Effective site management and new site/PI identification.
    • Development and implementation of e-CRFs and other study tools.

    Experience

    • Previous experience in managing clinical trials, specifically in a leadership or senior project management role.

    Educational Qualification

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

    Competencies

    • Accountability: Responsible for project success and delivery.
    • Communication: Strong verbal and written communication skills to liaise with stakeholders.
    • Work Ethic: Efficient, disciplined, and focused on completing tasks.
    • Initiative: Proactive and able to drive project progression.
    • Leadership: Lead project teams and provide guidance.
    • Technical Knowledge: Expertise in clinical trial management, regulations, and GCP.
    • Motivation/Initiative: Self-driven to improve project outcomes.
    • Interpersonal Skills: Strong teamwork and collaboration skills.
    • Flexibility/Planning & Organizing: Ability to adapt and efficiently organize resources.

    How to Apply

    Interested candidates are encouraged to apply through Lambda Therapeutic Research Ltd.'s official careers portal.

    Feel free to reach out if you need further details or modifications!

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