Clinical Research Lead

1 week ago

Melbourne, Victoria, Australia beBeeMedicalAdvisor Full time $150,000 - $180,000

Job Description:

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You will be responsible for the development of global clinical trials. This includes 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.

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About The Role:

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

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Key Responsibilities:

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  • 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.">
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Essential Requirements:

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  • A medical degree is 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.">
  • Experience in haematology and oncology clinical trials is valuable.">
  • Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective.">
  • Outstanding internal and external stakeholder engagement experience.">
  • Location based in Sydney, with flexible working options.">
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Commitment To Diversity And Inclusion / EEO Paragraph:

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

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We help people with disease and their families by combining innovative science with passionate people like you. Collaborating, supporting and inspiring each other to achieve breakthroughs that change patients' lives.

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