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CRA - Study Start Up - Job Opportunity at Novo Nordisk

Sydney, Australia
Contract
Mid-level
Posted: April 7, 2025
On-site
AUD 95,000 - 120,000 per year based on Sydney market rates for mid-level CRA positions

Benefits

Competitive healthcare and insurance benefits
Professional development opportunities
Global exposure working with international teams
Dynamic healthcare industry environment
12-month contract term with potential for extension

Key Responsibilities

Drive site selection and activation process for clinical trials
Develop and execute Study Start Up (SSU) strategies
Manage site relationships and contractual negotiations
Oversee regulatory compliance and documentation
Coordinate Site Initiation Visits and handover processes

Requirements

Education

Degree or equivalent in life science, medical or pharmacy

Experience

Minimum 2 years working in clinical research

Required Skills

Clinical trial methodology knowledge ICH GCP knowledge Regulatory process expertise Negotiation skills Presentation abilities Microsoft Office proficiency CTMS and eTMF systems experience Budget management Risk assessment capabilities
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Sauge AI Market Intelligence

Industry Trends

The clinical research sector is experiencing rapid growth due to increased focus on expedited trial processes post-COVID-19 There's a growing emphasis on technology integration in clinical trials, particularly in study startup phases The Asia-Pacific region is becoming increasingly important in global clinical trials, with Australia serving as a key hub Regulatory harmonization efforts are creating new opportunities for streamlined trial processes

Role Significance

Typically part of a 5-10 person clinical operations team, working with multiple stakeholders across sites and departments
Mid-level position with significant autonomy in study startup coordination and site management

Key Projects

Clinical trial site activation and setup Regulatory submission coordination Site contract and budget negotiations Quality assurance and compliance management Cross-functional team collaboration initiatives

Success Factors

Strong understanding of Australian clinical trial regulatory landscape Exceptional stakeholder management abilities Detailed knowledge of GCP and trial methodology Effective negotiation and communication skills Ability to work in a fast-paced, deadline-driven environment

Market Demand

High demand with strong growth trajectory due to increasing clinical trial activity in Asia-Pacific region and Australia's favorable regulatory environment

Important Skills

Critical Skills

Regulatory knowledge and GCP compliance expertise - essential for ensuring trial validity and compliance Stakeholder management skills - crucial for coordinating between sites, sponsors, and internal teams Technical proficiency with clinical trial management systems - fundamental for efficient trial coordination

Beneficial Skills

Legal knowledge for contract review and negotiation Project management methodologies Understanding of electronic systems validation Knowledge of local healthcare systems and networks

Unique Aspects

Opportunity to work with a leading global healthcare company in a key regional market
Focus on high-priority therapeutic areas including diabetes and obesity
Strong potential for international career development
Exposure to cutting-edge clinical research methodologies

Career Growth

2-3 years in current role before progression to senior positions, with potential fast-track options based on performance

Potential Next Roles

Senior CRA Clinical Project Manager Clinical Operations Manager Regional Trial Manager Study Start-Up Manager

Company Overview

Novo Nordisk

Novo Nordisk is a global leader in diabetes care and biopharmaceuticals with over 100 years of innovation history

Top-tier pharmaceutical company with strong market presence and continuous growth in the Asia-Pacific region
Established presence in Oceania with significant investment in clinical research infrastructure
Progressive, research-driven environment with strong emphasis on professional development and global collaboration
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