Clinical Operations Leader

1 week ago

Australia beBeeStudy Full time $79,999 - $149,999
Job Title: Study Start-Up Manager

Job Description

The SSO Study Start-Up Manager is accountable for planning, executing and activating assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country or satellite country.

  • Supports country SSU strategy by collaborating with the SSO Study Start-Up Team Lead, SSO Country Head Portfolio and SSO Cluster Head Portfolio.
  • Collaborates with global study team to ensure timely start-up activities from country allocation until Green Light (ready to initiate site milestone) are conducted according to country commitments.
  • Ensures close collaboration with local IRBs/IECs and Health Authorities as applicable.
  • Conducts and completes study start-up activities on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms and engaging Regulatory Affairs/CTA Hub for Health Authorities submissions as required.
  • Coordinates timely response to deficiency letters in collaboration with local and global stakeholders.
  • Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable.
  • Accountable for timelines, accuracy and quality of country TMF documents in study start-up to ensure TMF inspection readiness.
  • Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
  • Implements innovative and efficient processes which are in line with Novartis strategy.
  • Supports study feasibility by collaborating with Feasibility Manager and Site Partnership Manager as well as the global study team.
  • Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned.
  • Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary.
  • Ensures sites are prepared for 'Green Light' and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site 'Green Light.'
  • Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution according to Novartis standards and local and international regulations.

Required Skills and Qualifications

  • A degree in scientific or health discipline required, and an advanced degree with clinical trial experience and/or project management is preferable.
  • Fluent in both written and spoken English.
  • Minimum 5 years' experience in clinical operations in a role that oversees project management and/or with monitoring clinical trials.
  • Capable of leading in a matrix environment without direct reports.
  • Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution and monitoring.

Benefits

  • Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues.
  • Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards, health authorities and local/National Health Authorities regulations.
  • Strong interpersonal, negotiation and conflict resolution skills.
  • Communicates effectively in a local/global matrixed environment.

Others

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