Regulatory Submissions Manager (Study Start Up)

Overview:

Our client is a full-service clinical contract research organisation (CRO). They deliver Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

Their purpose is to accelerate the global development of safe and effective medical therapeutics through systematic and thorough methodology. They cover all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

Responsibilities:

• Efficiently oversee and successfully execute all aspects of global start-up
• Complete quality checks on submission documents and site essential documents
• Formulate and approve informed consent forms
• Review pertinent regulations to develop proactive solutions to start-up issues and challenges
• Present during bid defences, general capabilities meetings, and audits

Qualifications:

• More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience
• Regional experience will be highly advantageous
• Strong oral and written communication skills

Why this opportunity is right for you

• Fantastic opportunity to work with a fast-growing CRO
• Personalised fast training program based on your experience
• Low staff turn over
• Established career progression paths.

How to Apply

Click apply or contact Maddy Rhodes-Laird, Senior Recruitment Consultant on 03 9938 7101 for a confidential discussion.