Global Study Start-Up Lead (Clinical Ops) — Auckland

Roche; Auckland; On-site; NZD 140,000 - 190,000; Full time

Job summary

Roche in Auckland, New Zealand is seeking an experienced Study Start Up Lead to drive country strategy for trial initiation, coordinating with ethics boards, health authorities and CROs to bring therapies to patients faster.

The role emphasizes regulatory compliance, start-up execution, ICF management, budgeting, and process improvements in a global clinical operations context; requires 4+ years in start-up and fluent English, with NZ work eligibility.

Qualifications

• Degree in Life Sciences; postgraduate or master’s desirable.
• Solid understanding of ICH-GCP and local regulatory frameworks.
• Experience coordinating vendor and CRO relationships.

Responsibilities

• Develop and implement country-level start-up strategies and site activation.
• Oversee regulatory submissions, health authority queries and amendments.
• Manage ICF preparation, submission and maintenance.
• Oversee site budgets, FMV-based contracts and compliance.
• Identify opportunities for process automation and improvement.
• Collaborate with regional/global teams and health authorities.

Skills

Clinical systems

Vendor management

Communication

Organization

Cross-functional collaboration

English proficiency

Education

Degree in Life Sciences

Tools

Veeva Vault

CTIS

RIM

Job description

Roche in Auckland, New Zealand is seeking an experienced Study Start Up Lead to drive country strategy for trial initiation, coordinating with ethics boards, health authorities and CROs to bring therapies to patients faster.

The role emphasizes regulatory compliance, start-up execution, ICF management, budgeting, and process improvements in a global clinical operations context; requires 4+ years in start-up and fluent English, with NZ work eligibility.