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Global Clinical Trial Specialist

2 weeks ago


Sydney, New South Wales, Australia beBeeClinical Full time $150,000 - $180,000
Job Overview

This role is focused on the development of Global Clinical Trials, including medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning.

The successful candidate will drive compliance across all aspects of clinical trials and CRMA related activities. Ensuring good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams will be critical to success.

Key Responsibilities
  • Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards.
  • Drive portfolio/trial medical feasibility within the Global Development framework and provide country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team.
  • Identify and propose new sites for clinical trials, analyse capability, assess patient pool and country treatment landscape, and make recommendations for potential trial inclusion.
  • Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed.
  • Responsible for medical related education, implementation and compliance to protocol, standards (SOPs) and best practices for clinical development within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
  • Provide medical expertise to clinical/operational activities for patient eligibility, medical question-management, safety, amendments, etc.
  • Collaborate cross-functionally for the early product launch planning process to ensure Global Development trials conducted are aligned with the local country strategy.
  • Support medical/clinical team discussions with local regulatory interactions as needed.
Essential Requirements
  • Mbbs degree holder required.
  • Proven experience in medical practice or pharmaceutical industry experience with a background in clinical trials/medical affairs/life sciences/research in all aspects of drug development including clinical research, GCP, and local regulatory requirements.
  • Haematology and Oncology clinical trials experience preferred.
  • Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective.
  • Outstanding internal and external stakeholder engagement experience required.
  • Location based in Sydney with flexible working options available.
Commitment To Diversity And Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Work With Us

We help people with disease and their families by combining innovative science with passion, collaboration, and inspiration.

Ready to create a brighter future together?

For more information about our culture, visit Careers page.

Benefits And Rewards

We offer various benefits and rewards to help you thrive personally and professionally. Read more in our handbook: Benefits page.