Offer summary

Qualifications:

Degree in Life Sciences or related field; advanced qualifications preferred., 8+ years in clinical operations, with 2+ years in centralized monitoring or trip report review., Previous CTL/Lead CRA/management experience., Expertise in ICH-GCP guidelines and regulatory compliance. .

Key responsabilities:

Review monitoring visit reports and provide mentorship to CRAs and team members.

Identify risks and communicate trends to study teams.

Execute and oversee central monitoring activities, including study analytics and risk assessment.

Collaborate on regulatory readiness and ensure effective cross-functional team coordination.

Job description

We are seeking an experienced professional to lead central clinical operation activities, ensure the quality of clinical trial processes, and proactively manage risk. As a Centralized Clinical Team Lead, you will play a vital role in ensuring compliance, mentoring teams, and delivering data-driven insights that enhance trial outcomes.

Key Responsibilities:

Review monitoring visit reports, supporting trip report optimization and provide mentorship to CRAs and other team members.
Identify risks and communicate trends to study teams. Execute and oversee central monitoring activities, including study analytics, risk assessment, and mitigation planning.
Protocol deviation management including review and trend analysis.
Collaborate on regulatory readiness and ensure effective cross-functional team coordination.

Qualifications:

Degree in Life Sciences or related field; advanced qualifications preferred.
8+ years in clinical operations, with 2+ years in centralized monitoring or trip report review.
Previous CTL/Lead CRA/management experience.
Expertise in ICH-GCP guidelines and regulatory compliance.
Strong organizational, analytical, and interpersonal skills.

Learn more about our EEO & Accommodations request here.

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