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    Site Activation Managers, Sponsor Dedicated. Oncology Exp Essential. Homebased

    Syneos Health
    6+ years
    Not Disclosed
    Poland
    10 Jan. 16, 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

    Site Activation Manager - Sponsor Dedicated (Oncology Experience Essential)

    Updated: Yesterday
    Location: Poland (POL) - Home-Based
    Job ID: 25001112

    Position Overview

    Syneos Health® is a leading global biopharmaceutical solutions provider committed to accelerating customer success by translating clinical, medical affairs, and commercial insights into meaningful outcomes. We prioritize simplicity, collaboration, and continuous innovation to help deliver life-changing therapies.

    At Syneos Health, we are driven by a passion to improve lives. Join us and help shape the future of healthcare.

    WORK HERE MATTERS EVERYWHERE.

    Why Join Syneos Health?

    • Career Development: We provide opportunities for professional growth, including technical and therapeutic training, career advancement, and recognition through our Total Rewards Program.
    • Inclusive Environment: Our Total Self culture embraces diversity, ensuring you can bring your authentic self to work.
    • Employee Focused: We are committed to supporting our people and fostering an environment where everyone feels valued.

    Key Responsibilities

    1. Collaboration & Coordination

      • Partner with functional teams like Business Development, Clinical, Data Management, and Medical Writing to ensure project success.
      • Evaluate and address key issues in site start-up, regulatory processes, and patient enrollment.

    2. Site Start-Up & Lifecycle Management

      • Manage site identification, regulatory submissions, and documentation for site activation.
      • Oversee project timelines, adjusting as necessary for amendments or changes.

    3. Budget & Resource Oversight

      • Review and ensure project budgets align with milestones, making adjustments to meet profitability targets.
      • Track out-of-scope work and ensure all additional work is tracked and appropriately assigned.

    4. Documentation & Compliance

      • Prepare and maintain core clinical trial documents, and manage regulatory submissions.
      • Conduct Risk Impact Assessments and ensure timely submission of country-specific applications.

    5. Continuous Improvement

      • Contribute to change initiatives within the Site Start-Up department, always striving to improve processes and outcomes.

    Qualifications

    • Education: Bachelor’s degree required (higher degree preferred).
    • Experience:
      • At least 6 years in the CRO industry or 5 years in a Site Start-Up or clinical trial environment.
      • Expertise in Phases II-IV trials, ICH GCP, and EU CTR.
    • Skills:
      • Strong project management, organizational, and vendor management abilities.
      • Excellent communication, negotiation, and problem-solving skills.

    Why Syneos Health is a Great Choice

    Syneos Health has supported the development of 94% of all FDA-approved novel drugs and 95% of EMA-authorized products in the last five years. With over 200 studies across 73,000 sites and more than 675,000 trial patients, we make a significant impact on the global healthcare landscape.

    Additional Information

    This job description may be updated with additional responsibilities as necessary. Syneos Health is committed to compliance with the Americans with Disabilities Act and offers reasonable accommodations when appropriate.

     

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    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |