AstraZeneca1 follower6 jobs

Study Start Up Manager

Mid levelContractHybridNew South Wales, AustraliaProfessional servicesHealthcarePosted 11 hours agoVerified 4 days ago
Pending fitX of Y criteria met

About the job

This job is about leading the end-to-end start-up of oncology study sites at AstraZeneca. By managing ethics and regulatory submissions, as well as site-level contract and budget negotiations, you will play a crucial role in enabling timely and compliant activation of clinical trials. The team values collaboration and innovation, working cross-functionally to push the boundaries of science and deliver life-changing medicines.

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Think you're a good fit?See what the hiring team are looking for

You'll be responsible for

🚀

Driving site start-up activities

Drive site start-up activities, including ethics, governance and regulatory submissions, contract and budget negotiations and site activation across assigned clinical trials.
📑

Preparing submission documentation

Prepare, review, and coordinate submission of ethics (HREC), research governance (RGO) and regulatory (TGA) documentation, ensuring high-quality and compliant submission packages to facilitate timely approvals.
💰

Leading contract negotiations

Lead contract and budget negotiations with clinical sites, ensuring alignment with fair market value (FMV), optimising cost efficiency and supporting study timelines - processing contract amendments as needed.

Key criteria

📄

Clinical study start-up experience

Demonstrated experience in clinical study start-up within Australia.

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💼

Contract negotiation skills

Proven skills in contract and budget negotiations with clinical sites.

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📊

Regulatory submission knowledge

Experience with HREC, RGO, and TGA submissions for compliance.

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View your fit

5 criteria for this job
Clinical study start-up experience
Demonstrated experience in clinical study start-up within Australia.

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Contract negotiation skills
Proven skills in contract and budget negotiations with clinical sites.

View

Regulatory submission knowledge
Experience with HREC, RGO, and TGA submissions for compliance.

View

ICH-GCP familiarity
Strong knowledge of ICH-GCP and local regulatory frameworks.

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Organisational skills
Proven ability to manage timelines and meet deadlines effectively.

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