Regulatory Submissions Lead – Study Start-Up

Medpace; Melbourne; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths with opportunities for professional growth

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Job summary

A leading clinical research organization is seeking a full-time Regulatory (Study Start Up) Submissions Manager in Melbourne. The role involves managing global start-up processes, performing quality checks on documents, and preparing consent forms. Candidates should have over 5 years in clinical research, with strong communication skills being essential. This position allows for potential hybrid working arrangements, promoting flexibility and professional growth in a rewarding work environment.

Qualifications

• More than 5 years of experience in clinical research, preferably with a CRO.
• Regional experience will be highly advantageous.
• Strong oral and written communication skills.

Responsibilities

• Efficiently manage and successfully execute all aspects of global start-up.
• Perform quality checks on submission documents and site essential documents.
• Prepare and approve informed consent forms.
• Review pertinent regulations to develop proactive solutions to start-up issues.
• Present during bid defenses, general capabilities meetings, and audits.

Skills

Clinical research experience

Strong oral communication skills

Strong written communication skills

Project management experience

Job description

A leading clinical research organization is seeking a full-time Regulatory (Study Start Up) Submissions Manager in Melbourne. The role involves managing global start-up processes, performing quality checks on documents, and preparing consent forms. Candidates should have over 5 years in clinical research, with strong communication skills being essential. This position allows for potential hybrid working arrangements, promoting flexibility and professional growth in a rewarding work environment.