Auckland Study Start-Up Lead - Global Clinical Ops

Roche Holding AG; Auckland; On-site; NZD 140,000 - 200,000; Full time

Job summary

Roche Holding AG in Auckland, New Zealand is seeking an experienced Study Start Up Lead (SSUL) to drive country start-up strategy, regulatory submissions, and cross-functional collaboration within the PDG Global Clinical Operations team.

You will bridge local operations with global strategies, oversee ICF management, contracts, and budgeting, and lead process improvements across start-up activities while ensuring compliance and timely trial initiation.

Qualifications

• Requires degree in Life Sciences or equivalent with minimum 4 years of study start up experience.
• Postgraduate or Master’s degree highly desirable.

Responsibilities

• Develop and implement country-level start-up strategies.
• Oversee regulatory and health authority submissions and amendments.
• Manage Informed Consent Form (ICF) preparation and maintenance.
• Oversee site budgets, FMV-based contracts, and compliance.
• Drive process automation and continuous improvement in start-up operations.
• Collaborate with regional/global teams and external authorities.
• Engage affiliates in strategic planning and cross-functional initiatives in New Zealand.

Skills

Clinical operations

Regulatory knowledge

Vendor management

Cross-functional collaboration

English fluency

Education

Life Sciences degree

Postgraduate/Master's preferred

Tools

Veeva Vault

CTIS

RIM

Job description

Roche Holding AG in Auckland, New Zealand is seeking an experienced Study Start Up Lead (SSUL) to drive country start-up strategy, regulatory submissions, and cross-functional collaboration within the PDG Global Clinical Operations team.

You will bridge local operations with global strategies, oversee ICF management, contracts, and budgeting, and lead process improvements across start-up activities while ensuring compliance and timely trial initiation.