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    Clinical Trial Manager Ii

    Syneos Health
    0-2 years
    Not Disclosed
    Remote
    10 Jan. 18, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Position: Clinical Trial Manager II (Client Base)
    Location: India-Asia Pacific - IND-Home-Based, India
    Job ID: 24007021
    Updated: January 8, 2025

    Company Overview

    Syneos Health® is a fully integrated biopharmaceutical solutions organization, committed to accelerating customer success. They focus on clinical, medical affairs, and commercial insights to drive outcomes for modern market realities. Syneos Health fosters an environment of collaboration, diversity, and innovation with a mission to change lives by streamlining and simplifying clinical development.

    Role Overview

    The Clinical Trial Manager II will oversee site management, clinical monitoring, and central monitoring deliverables to ensure patient safety, protocol compliance, and data integrity. The role requires close interaction with site teams, management of clinical trials, and execution of risk mitigation strategies. The position is home-based in India and involves moderate travel (approximately 20%).

    Key Responsibilities

    • Site & Clinical Monitoring:
      • Oversee site interactions post-activation through closeout, including patient recruitment and investigator payments.
      • Ensure clinical trial deliverables are met, including regulatory and protocol compliance.
      • Review study scope, budget, and protocol, ensuring alignment with team members (CRAs/CeMs).
      • Use clinical experience and data to identify risks to trial management deliverables.
      • Lead risk mitigation strategies and escalate any significant risks to the project manager.
    • Team Coordination:
      • Collaborate with cross-functional teams (Study Start Up, Data Management, etc.) to meet study milestones (site activation, enrollment targets, database lock timelines).
      • Provide oversight and training to study teams on protocol, Case Report Form (CRF) completion, and other essential aspects.
      • Ensure adequate resourcing, site assignments, and study team conduct.
      • Support corrective actions to ensure timely delivery and quality control of study milestones.
    • Client & Stakeholder Communication:
      • Serve as an escalation point for site-related concerns and maintain effective communication with principal investigators and site staff.
      • Provide updates to clients and project management on trial progress and risks.
      • Monitor and oversee all trial activities through systems like CTMS, EDC, and IVRS/IWRS.

    Qualifications

    • Education:
      • Bachelor’s degree or RN in a related field or equivalent experience.
    • Experience:
      • Strong experience in site management and clinical trial monitoring.
      • Proven ability to lead teams and manage risks to ensure project milestones are met.
      • Preferred experience with risk-based monitoring.
      • Familiarity with ICH GCP guidelines, regulatory requirements, and clinical trial financial management.
    • Skills:
      • Strong problem-solving, conflict resolution, and critical thinking skills.
      • Effective communication, presentation, and interpersonal skills.
      • Good computer skills and experience with clinical trial management systems.

    Why Syneos Health

    • People Development: Syneos Health offers career development, technical training, and a supportive work environment.
    • Inclusive Culture: The company values diversity and encourages employees to be their authentic selves.
    • Global Impact: Be part of a company that has worked on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the last 5 years.

    Additional Information

    • Travel: Moderate, approximately 20%
    • Tasks, duties, and responsibilities may be adjusted at the company’s discretion.

     

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