Job Description

Bachelor's degree in Life Sciences or related field required; advanced degree (MS, PharmD, PhD) a plus.

6+ years of clinical operations experience, with at least 4+ years managing global oncology trials in biotech/CRO setting.

Experience in managing cross-functional, global clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.

Strong experience in vendor and CRO oversight

Strong understanding of FDA/EMA/ICH-GCP guidelines, and full-service clinical development processes.

Desired Skills and Experience

Key Responsibilities:

Act as the central liaison for both internal stakeholders and external collaborators, including monitoring teams, contract research organizations (CROs), vendors, and clinical sites.
Create and manage comprehensive project plans, including timelines, budgets, operational strategies, and risk assessments.
Contribute to the development and refinement of study protocols, consent forms, site evaluations, and essential study documentation.
Foster strong site relationships and proactively address operational challenges in coordination with cross-functional teams such as Medical, Regulatory Affairs, Clinical Supplies, Sample Management, and Data Operations.
Oversee third-party service providers to ensure adherence to quality standards, contractual terms, and project milestones.
Lead regular cross-functional team meetings, ensuring clear documentation of key decisions and action items.
Support the evolution of internal processes by contributing to the enhancement of standard operating procedures, tools, and best practices.

Job Tags

Contract work,

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