Study Start Up Associate

Benefits

24 months Contract - potential to go permanent

Flexible working hours

Supportive learning and development opportunities

Attractive salary package plus benefits

About the Company

A Global pharmaceutical company committed to bringing discovery to life and ensuring that the necessary research and development is conducted to provide medicines to the people who need it most. This company pride themselves on many medical breakthroughs especially in chronic disease management.

About the opportunity

As a Study Start Up Specialist you will serve as a subject matter expert on all SSU-related activities. You will be responsible for SSU process development and patient recruitment strategies, as well as successfully supporting the Clinical Operations team from study initiation to study closure.

Responsibilities

• Manage the distribution of the Global Site Services (GSS) component of assigned studies within a country or region. (Involving overall responsibility for delivery to cost, time and quality)
• Maintain up to date information, ensure adherence and compliance with local regulatory obligations and related documentation
• Act as primary contact for investigative sites throughout site start-up activities
• Develop and maintain a relationship with key site staff to influence timely collection of required regulatory documents for site activation
• Guarantee all start up information & requirements are kept up to date in a central location for project teams
• Work with staff in Business Development and Operational Strategy & Planning to provide feasibility data and additional applicable data.
• Identify possible issues with trial progress to create and execute project management and contingency plans at the study-level

Skills & Experience

• Recognise, observe, and reinforce local regulations, laws, and guidance (e.g., MOH, Privacy, Codes of Conduct), Medical Quality Systems (MQS) Standards and Procedures, Good Clinical Practices (GCP) and Ethics & Compliance

• Strong interpersonal skills, including the ability to participate in professional relationship building and networking
• Capability to implement and execute within a fast-paced environment
• Exceptional written and verbal communication skills
• Solid negotiation skills
• Minimum twelve months experience in clinical research roles working on Study Start Up
• Proven decision-making ability
• Robust organisational, and problem-solving skills
• Outstanding teamwork/interpersonal skills

How to Apply

Click apply or contact Chanelle Wilson, Recruitment Consultant on 02 8877 8772 or cwilson@hpgconnect.com for a confidential discussion.