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

6+ years
Not Disclosed
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: Turkey (TUR) - Home-Based
Job ID: 25001112


Position Overview

Syneos Health® is a global leader in biopharmaceutical solutions, committed to accelerating customer success by integrating clinical, medical, and commercial insights into outcomes that address modern market challenges. We work to simplify clinical trials and deliver therapies that change lives, with a deep passion for what we do.

At Syneos Health, we empower employees to bring their best selves to work and collaborate to make a significant impact in clinical development.

WORK HERE MATTERS EVERYWHERE.


Why Join Syneos Health?

  • Career Development: We offer ongoing training, career progression, and a rewarding work environment.
  • Inclusive Culture: We celebrate diversity and create an environment where everyone can be their authentic selves.
  • Engaged Leadership: Collaborative and supportive leaders who foster personal and professional growth.

Key Responsibilities

  1. Collaboration & Coordination

    • Work across various functions, including Business Development, Project Management, and Clinical teams, to ensure seamless project execution.
    • Address critical issues such as site start-up, regulatory pathways, and patient enrollment.
  2. Site Start-Up & Lifecycle Management

    • Oversee site selection, regulatory submissions, and essential document collection leading to site activation.
    • Manage project timelines and realign them as needed to meet targets.
  3. Budget & Resource Oversight

    • Review and manage project budgets, ensuring financial health and profitability.
    • Monitor out-of-scope work and manage any required adjustments.
  4. Documentation & Compliance

    • Prepare clinical trial documentation and ensure amendments are handled efficiently during the lifecycle.
    • Conduct Regulatory Impact Assessments and manage risk mitigation.
  5. Continuous Improvement

    • Contribute to change initiatives and improvements across the SSU department.

Qualifications

  • Education: Bachelor's degree required (higher degree preferred).
  • Experience:
    • Minimum of 6 years in the CRO industry or 5 years in SSU/clinical trial environments.
    • Comprehensive understanding of Phases II-IV trials, ICH GCP, and EU CTR.
  • Skills:
    • Strong project management, organizational, and vendor management skills.
    • Excellent communication, negotiation, and problem-solving abilities.

Why Syneos Health Stands Out

With a proven track record, Syneos Health has worked with 94% of FDA-approved drugs and 95% of EMA-authorized products in the past five years, contributing to over 200 studies and thousands of trial patients.


Additional Information

This job description may evolve with additional responsibilities. Syneos Health is committed to providing equal opportunities and reasonable accommodations as needed for employees or applicants.