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    Senior Clinical Project Manager - Søborg, Danmark - TFS HealthScience

    TFS HealthScience
    TFS HealthScience Søborg, Danmark

    for 1 uge siden

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    Fuldtid
    Beskrivelse

    Join our innovative team at TFS HealthScience as we continue our commitment to advancing clinical research and improving patient outcomes. We are currently seeking a talented Senior Clinical Project Manager to lead clinical studies and drive the development of life-changing treatments.

    This position is sponsored-based.

    About Us:

    TFS HealthScience is a leading mid-sized Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. With a focus on excellence and innovation, we strive to deliver high-quality solutions that make a difference in patients' lives.

    The Role:

    As a Senior Clinical Project Manager, you will play a crucial role in overseeing the strategic and operational aspects of clinical studies. Reporting to the VP of Clinical Development, you will lead a cross-functional study management team (SMT) and ensure the successful execution of clinical trials.

    Key Responsibilities:

  • Lead and manage all activities related to assigned clinical studies, ensuring adherence to quality, budget, and timelines.
  • Provide project leadership to the study management team (SMT) and collaborate with internal and external stakeholders to drive study success.
  • Plan, execute, and oversee clinical study activities, including start-up, operational conduct, and closure, in accordance with regulatory requirements and industry standards.
  • Contribute to the selection and oversight of CROs and vendors, including risk assessment and quality management.
  • Ensure inspection readiness of the TMF
  • Develop and implement the Sponsor Oversight Plan, ensuring effective oversight of clinical studies and inspection readiness of essential documents.
  • Communicate study timelines, milestones, and progress to internal stakeholders and sponsor teams.Qualifications:
  • Bachelor's degree in life sciences or related field.
  • Extensive experience in project leadership within the pharmaceutical industry, including clinical study management (phase I-III).
  • Extensive knowledge of global clinical study management and the drug development process.
  • Proficiency in GCP guidelines, regulatory requirements, and clinical trial processes.
  • Strong analytical and communication skills, both written and verbal, in English.
  • Prior experience in oncology and/or rare disease therapeutic areas is preferred.What Can We Offer You:
  • A Rewarding Career: Elevate your career in a global environment filled with growth opportunities.
  • Diverse and Dynamic Team: Join passionate experts from around the world who prioritize patients, saving lives, and improving their quality of life.
  • Health and Well-being: Enjoy comprehensive preventative private healthcare solutions for you and your loved ones.
  • Career Advancement: Explore numerous career progression opportunities within our organization.
  • Supportive Leadership: Work with an excellent, highly experienced local manager who will guide and mentor you.
  • Positive Team Culture: Be part of a team that values a healthy work-life balance and fosters a supportive and positive work environment.

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