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    Ssu Project Delivery Lead

    Syneos Health
    5-6 years
    Not Disclosed
    India
    10 Dec. 1, 2024
    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

    The Site Start-Up Project Delivery Lead position at Syneos Health is a senior role that requires experience in clinical trial start-up processes, project management, and cross-functional collaboration. Here’s a summary of the role:

    Position Overview

    Location: Home-Based, India-Asia Pacific
    Updated: November 20, 2024
    Job ID: 24006309

    As a Site Start-Up Project Delivery Lead, you will manage and oversee all aspects of the site start-up phase of clinical trials, ensuring successful regulatory submissions, site activations, and trial initiation. You will be responsible for ensuring that all project deliverables align with both client expectations and internal standards, collaborating with cross-functional teams to identify and resolve issues and risks.

    Key Responsibilities

    1. Project Management & Collaboration:

      • Lead the site start-up activities across multiple regions, collaborating with teams like SSU Country Managers, Clinical Management, and Project Management.
      • Ensure project deliverables, timelines, and client expectations are met, providing regular progress reports, updates, and risk assessments.

    2. Regulatory & Compliance Oversight:

      • Oversee regulatory activities like submissions, communication with ethics committees, and the collection of essential documents leading to site activation.
      • Ensure all required approvals, including clinical trial agreements (CTAs) and investigator budgets, are executed on time.

    3. Site Activation & Timeline Management:

      • Develop and manage integrated site start-up timelines, ensuring timely delivery of study milestones.
      • Provide regular status updates on SSU strategy and progress to clients and internal stakeholders.

    4. Financial Oversight & Resource Management:

      • Manage SSU budgets, ensuring that the project stays within budget and meets profitability expectations.
      • Use planning tools to manage scope, timelines, and resources efficiently, escalating any out-of-scope work.

    5. Business Development & Client Relationships:

      • Maintain strong relationships with clients and contribute to new business development by participating in client presentations.
      • Support the development of proposals, contracts, and alliances to secure new projects.

    6. Process Improvement & Training:

      • Identify best practices and contribute to process improvement initiatives.
      • Support the development of training programs, SOP updates, and quality assurance within the SSU team.

    Qualifications

    • Education:

      • Bachelor’s degree (Higher degree preferred).
      • Minimum of 6 years of experience in the CRO industry or at least 3 years in Site Start-Up or clinical trial management.

    • Experience:

      • Proven experience in leading/co-leading 5+ studies, including those involving multiple countries (at least 2 studies across 10+ countries).
      • Strong understanding of clinical trial processes, ICH GCP, and the site start-up phase.
      • Experience in project management, vendor management, and negotiation.

    • Skills:

      • Strong communication, presentation, and negotiation skills.
      • Demonstrated ability to solve problems, manage multiple projects, and meet deadlines.
      • Quality-driven and capable of providing guidance and feedback to peers.

    Why Syneos Health?

    • Innovative Culture:
      • Work in an environment where collaboration, diversity, and inclusion are valued.
      • Contribute to the delivery of innovative therapies across global clinical trials, helping shape the future of healthcare.

    Application Information

    Syneos Health encourages diverse candidates with transferable skills to apply, and also invites individuals to join their Talent Network for future opportunities. If you are ready to apply, visit the application link provided.

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