Lead site activation strategy and execution for clinical trials across multiple regions, managing regulatory submissions, site selection, and contracting to support timely patient enrollment. Report to sponsors while ensuring compliance with ICH-GCP and regulatory requirements.
Responsibilities
- Direct strategic oversight and project management of global or multi-regional site activation activities
- Lead pre-award through activation phases and maintain lifecycle compliance with ICH-GCP standards
- Develop and execute Site Activation Management Plans aligned with study strategy and scope
- Oversee regulatory submissions, approvals, contracts, and essential documentation processes
- Assess regulatory landscapes, identify risks, and propose solutions to support study delivery
Requirements
- Bachelor's degree in Life Sciences or related field
- 5-7 years clinical research experience with 3+ years in leadership role
- Proven international project management across multiple regions
- Strong leadership, negotiation, and stakeholder management abilities
- Expertise in regulatory processes and clinical trial compliance
- Demonstrated ability to deliver projects on time and within budget
Vacancy posted 15 days ago
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