This role involves leading the operational strategy and execution of select global clinical studies within assigned oncology programs while ensuring strict compliance with ICH GCP and local regulations
Job Summary
This role involves leading the operational strategy and execution of select global clinical studies within assigned oncology programs while ensuring strict compliance with ICH GCP and local regulations.
The successful candidate will manage strategic partners and CROs, oversee budget development, and serve as the primary escalation point for all vendor-related issues to ensure on-time and on-budget delivery.
Join a global team at Thermo Fisher Scientific that values passion and innovation, offering an environment where collaboration and scientific excellence drive breakthrough contributions.
Matching Summary
This role involves leading the operational strategy and execution of select global clinical studies within assigned oncology programs while ensuring strict compliance with ICH GCP and local regulations.
Skills & Requirements
Must-have
8+ years pharmaceutical industry experience
3+ years clinical study management oversight
Oncology therapeutic area expertise required
Global regulatory compliance (ICH GCP/CFR)
Strategic partner and CRO vendor management
Clinical trial budget development and tracking
Cross-functional team leadership skills
Nice-to-have
Experience in early phase or Phase 2/3 studies
Advanced degree in Life Sciences preferred
Fluent business English communication skills
Strong problem-solving and organizational abilities
Experience with multiple therapeutic areas
Key Requirements
Bachelor's Degree required; Life Sciences preferred
Minimum 8 years pharmaceutical or CRO experience
Minimum 3 years clinical study management experience
Minimum 2 years global lead project management
Required Oncology experience as Lead PM or Lead CTM
Extensive Informed Consent Form (ICF) experience required