Clinical Team Lead.

The Clinical Trials Regulatory Specialist is responsible and accountable for ensuring that inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study.
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YOUR KEY RESPONSIBILITIES:

  • Lead all aspects of global clinical trials to deliver study outcomes within schedule, budget, quality/compliance and performance standards.
  • Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
  • Conduct study start-up activities such as being responsible for protocol development, CRF development, Informed Consent Form development.
  • May identify new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
  • Ensuring accurate handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
  • Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
  • Responsible for clinical execution and management of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations etc.) executed by NBS CONEXTS on behalf of Novartis Organizations.
  • WHAT YOU’LL BRING TO THE ROLE:

    • Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing

    Minimum requirements

    • Bachelor’s Degree or above, English proficiency
    • At least 3-10 years’ of Clinical Operations experience with managerial experience in planning, executing, reporting and publishing Global clinical studies in a pharmaceutical company or contract research organization.
    • Clinical Research Phases Clinical Trial Set-up, Management & Conduct Relevant educational background in life sciences/Healthcare
    • Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
    • Working in multi-national context and across countries
    • Strong customer orientation; Experience in working with different cultures, team located worldwide and cross-functionally; Demonstrated presentation and tact skills. Negotiation and conflict resolution skills.
    • Proven track record to work independently in a sophisticated matrix environment (including remote).

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