Head of Study Start Up

Job Title: Head of Study Start-Up
Location: Melbourne, Australia

Company Overview:
Our client is a leading Contract Research Organisation (CRO) with a reputation for delivering high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. They are seeking a dynamic and experienced Head of Study Start-Up to join and lead the initiation of clinical trials across various therapeutic areas.

Role Purpose:
As the Head of Study Start-Up, you will be responsible for overseeing and managing the study start-up process for clinical trials. This includes site identification, feasibility assessments, ethics submissions, and contract negotiations. Your leadership will be critical in ensuring that trials are initiated efficiently and in compliance with all regulatory requirements, setting the foundation for successful study execution.

Key Responsibilities:

• Lead and manage the study start-up team, ensuring the timely and efficient initiation of clinical trials.
• Oversee the site selection process, including feasibility assessments and site qualification visits.
• Manage the preparation and submission of ethics and regulatory applications, ensuring compliance with local and international guidelines.
• Negotiate site contracts and budgets, working closely with the legal and finance teams.
• Develop and implement standard operating procedures (SOPs) and best practices to optimize the study start-up process.
• Collaborate with cross-functional teams, including project management, clinical operations, and business development, to ensure alignment on study timelines and objectives.
• Provide leadership and mentorship to study start-up staff, fostering a culture of excellence and continuous improvement.
• Monitor study start-up progress and report on key metrics to senior management and sponsors.

Qualifications & Experience:

• Essential: Bachelor's degree in life sciences, clinical research, or a related field.
• Experience: Minimum of 7 years of experience in clinical research, with at least 3 years in a study start-up or regulatory affairs role within a CRO.
• Desirable: Experience in a leadership role with a proven track record of managing successful study start-ups across multiple therapeutic areas.

Knowledge & Skills:

• Extensive knowledge of ICH/GCP guidelines, local regulatory requirements, and clinical trial methodologies.
• Strong leadership and project management skills, with the ability to manage multiple studies and teams simultaneously.
• Excellent communication and negotiation skills, with the ability to build strong relationships with sites, sponsors, and regulatory bodies.
• Proficiency in using clinical trial management systems (CTMS) and other relevant software.
• High level of attention to detail and the ability to work in a fast-paced, deadline-driven environment.

Why Join?
This is an exceptional opportunity to lead a critical function within a reputable CRO and make a significant impact on the success of clinical trials. Our client offers a competitive salary, comprehensive benefits, and opportunities for professional growth in a supportive and innovative environment.

How to Apply:
If you are an experienced clinical research professional with a passion for study start-up and leadership, we encourage you to apply. Feel free to reach out to Dana Sarkissian on 02 8310 5842 or dsarkissian@i-pharmconsulting.com

Take the lead in shaping the future of clinical research and be part of a team that is making a difference!