Senior Oncology Study Lead

2 weeks ago

Melbourne, Victoria, Australia beBeeClinical Full time $150,000 - $187,500
Job Title: Associate Director Clinical Operations

Oncology professionals manage the execution of clinical studies and provide operational oversight to partners, leadership, and management. They contribute to the overall strategy and oversee capabilities required to deliver clinical research.

Key Responsibilities:

  • Lead local/regional study execution activities related to technology development.
  • Participate in the Study Team to implement and oversee an operating model for clinical trial activities, working with stakeholders and vendors/CROs.
  • Contribute to trial design and translate scientific imperatives into operational delivery.
  • Review protocols, study plans, IP management plans, CSRs, and other trial-related documentation.
  • Advise on protocol development and ethics committee packages in alignment with regulatory requirements.
  • Partner with CRO(s) to build relationships and communication, and quality oversight and documentation.
  • Proactively identify risks and provide mitigation strategies.
  • Develop and maintain relationships with investigators and sites locally, including site visits.
  • Participate in investigator meetings/webinars, coordinating expert input.
  • Provide guidance on protocol and procedures in eCRF design and data management.
  • Monitor data quality and ensure quality measures are in place.
  • Ensure TMF completion and inspection readiness.
  • Assist the global team to build local operations capability as needed.
  • Ensure compliance with industry standards and partner with Quality teams.

Requirements:

  • BSc/PhD in a relevant scientific discipline.
  • At least 5 years of clinical research experience in industry (Pharma, biotech or CRO).
  • A broad understanding of drug development, including CMC, Regulatory, Safety, and non-clinical activities.
  • Experience leading trial site and CRO interactions.
  • Capability to innovate and guide trial activities where pathways are not well defined.
  • Experience in fast-paced environments.
  • Comfortable assimilating information and working on high-risk programmes.
  • Excellent communication skills.

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