Senior Clinical Trial Manager

  • plaats

    Florida

  • Sectoren:

    Life Sciences

  • soort baan:

    Blijvend

  • salaris:

    Negotiable

  • Contact:

    Sophie Summers

  • Contact email:

    Sophie.Summers@volt.eu.com

  • functie ref:

    BBBH10868_1658322073

  • gepubliceerd:

    meer dan 1 jaar geleden

  • Vervaldatum:

    2022-08-19

Volt have partnered with a boutique CRO on the lookout for a Senior Clinical Trial Manager. You will have the chance to become a vital part of a growing global company in the expanding clinical research industry. They have built a fantastic reputation for their highly customised and quality trials. You will have the opportunity to work on early phase oncology trials.


Responsibilities
- Responsible for ensuring the Clinical Team delivers timely and high-quality project deliverables.
- Site Management: Track and manage subject recruitment at all study sites. Oversee or supports the management of study Monitoring Visits, and review and approval of Monitoring Reports.
- Study Start-Up: Uses operational and therapeutic expertise to optimize trial execution.
- Document and Supplies Management: Oversee or support the collection, review and filing of site essential documents, and maintenance of the TMF.
- Compliances: Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies.
- Staff Management: Provides coaching and guidance to junior Clinical staff, and cross-functional working with other departments


Experience
- Bachelor's degree in a life science discipline
- 4+ years of Trial Management experience
- Strong experience working on early phase oncology trials
- Knowledge of medical terminology and clinical trial monitoring and management process.
- Strong understanding of ICH GCP and worldwide applicable regulatory requirements
- Document study conduct and management.
- Effective business skills for interactive situations with peers, sites, and clients