Senior Country Study Start-Up Lead (Australia)

AbbVie; Sydney; On-site; AUD 150,000 - 190,000; Full time

Job summary

AbbVie Australia is seeking a Senior Manager, Country Study Start Up to lead end-to-end start-up activities for clinical studies across Australia. You will own activation plans, manage ethics and regulatory submissions, and coordinate with Regulatory Affairs, Contracts and study teams to keep timelines on track.

You will mentor Country Start Up Specialists, drive process improvements, and promote the adoption of new technologies while ensuring compliance with ICH/GCP guidelines and company

Qualifications

• Bachelor's Degree (health care or scientific field) preferred or equivalent experience.
• Minimum 3 years of clinical research experience; 2+ years in study start up for the designated region.
• Experience with central and local IRB/EC sites and ICF review routing.
• Familiarity with ICH and GCP guidelines and regulatory environments.
• Experience working with remote/virtual teams.
• Strong analytical and communication skills; ability to drive cross-functional initiatives.
• Proven ability to mentor and train junior staff.

Responsibilities

• Lead start-up and maintenance activities for assigned sites/studies to ensure on-time, quality activation.
• Establish activation plans and risk mitigation with cross-functional leads.
• Coordinate ethics/regulatory submissions and local ICF/materials customization.
• Collaborate with Regulatory, CTS, Contracts, and site teams to align activation requirements.
• Track start-up metrics and maintain SSU databases/EDLs.
• Mentor and train Country Start Up Specialists; drive process improvements.

Skills

Analytical thinking

Cross-functional collaboration

Regulatory knowledge

Mentoring / training

Stakeholder management

Remote team experience

Education

Bachelor's Degree in health care or scientific field

Tools

Vault SSU

Job description

AbbVie Australia is seeking a Senior Manager, Country Study Start Up to lead end-to-end start-up activities for clinical studies across Australia. You will own activation plans, manage ethics and regulatory submissions, and coordinate with Regulatory Affairs, Contracts and study teams to keep timelines on track.

You will mentor Country Start Up Specialists, drive process improvements, and promote the adoption of new technologies while ensuring compliance with ICH/GCP guidelines and company