Global Site Management & RBQM Lead

BioSpace

New Jersey

Hybrid

USD 134,000 - 219,000

Full time

18 hours ago

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Job summary

Regeneron is seeking a Senior Manager, Global Site Management to join the Global Development team in a hybrid role supporting a global clinical trial portfolio. You will design and lead risk-based monitoring strategies, ensure site quality, and collaborate with CROs and internal stakeholders to drive study performance.

The role requires a Bachelor's degree with 8+ years in clinical research or related fields, familiarity with RBQM and ICH-GCP, and strong cross-functional leadership.

Qualifications

Bachelor's degree and 8+ years in clinical research or related pharma environments.
Strong RBQM, risk-based monitoring, and site management experience.
Experience supervising CROs/FSPs and external partners.
Knowledge of ICH-GCP and regulatory requirements.

Responsibilities

Lead risk-based monitoring and site management strategies across global programs.
Partner with CTM teams to identify data, risks and monitoring approaches.
Oversee CRO/FSP monitoring activities to ensure quality and compliance.
Evaluate metrics and KRIs to mitigate study risks.
Collaborate on study planning, budget forecasting, inspection readiness and operations.
Build relationships with sites and partners to drive performance and data quality.
Be RBQM subject-matter expert and contribute to process improvements.

Skills

RBQM knowledge

CRO oversight

Stakeholder management

Risk assessment

Education

Bachelor's degree

Job description

The role requires a Bachelor's degree with 8+ years in clinical research or related fields, familiarity with RBQM and ICH-GCP, and strong cross-functional leadership.

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