ICON Strategic Solutions1 follower2 jobs

Study Start Up- Lead

Mid levelFull-timeHybridSydney NSW, AustraliaProfessional servicesHealthcarePosted 3 months agoVerified 17 hours ago
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About the job

The Study Start-Up Lead position at ICON plc offers an exciting opportunity to play a critical role in the planning, submission, and activation of clinical trials across Australia. This job is essential for ensuring that clinical studies are initiated efficiently and in compliance with local regulations. The team values collaboration and innovation, working closely together to achieve shared goals.

You'll be responsible for

📋

Leading submissions

Leading and managing country-level submissions and approvals for assigned clinical studies.
📄

Coordinating documents

Preparing, reviewing, and coordinating local study documents, including informed consent forms and translations.
📦

Supporting processes

Supporting operational processes such as import/export, supplies management, and document archiving.

Key criteria

📅

3+ years of study start-up experience

Proven experience in clinical research within CRO or pharmaceutical settings.

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📜

Tertiary qualifications in relevant fields

Educational background in Life Sciences, Business, or related disciplines.

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⚖️

Strong understanding of regulatory requirements

Knowledge of local submissions processes and ICH-GCP standards.

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Meet the team

About the company

View your fit

5 criteria for this job
3+ years of study start-up experience
Proven experience in clinical research within CRO or pharmaceutical settings.

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Tertiary qualifications in relevant fields
Educational background in Life Sciences, Business, or related disciplines.

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Strong understanding of regulatory requirements
Knowledge of local submissions processes and ICH-GCP standards.

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Experience in budget development and contract negotiation
Demonstrated ability to coordinate with vendors and stakeholders.

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Excellent communication skills
Strong written and verbal skills for effective collaboration.

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