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Clinical Operations Leader at Parexel

England, Londonderry - Northern Ireland, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

03 Jan, 27

Salary

45000.0

Posted On

05 Oct, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Lead the development and execution of trial level site monitoring and oversight strategies, including monitoring risk assessments and site monitoring plans.
Provide oversight of CRO delivered site management and monitoring activities to ensure quality, compliance, and timely study execution.
Conduct trial level trend analysis, signal detection, risk identification, and issue management to support proactive decision making.
Drive a risk based site monitoring approach and ensure monitoring activities align with study objectives and quality requirements.
Collaborate with Clinical Trial Managers, Clinical Research Associates, and cross functional stakeholders to support study delivery against milestones and key performance indicators.
Participate in the development and maintenance of trial level documents, amendments, training materials, and monitoring related procedures.
Lead and contribute to trial oversight meetings, investigator meetings, and cross functional study discussions at global, regional, and local levels.
Conduct site and monitoring oversight activities, implement follow up actions, and escalate issues when required.
Serve as a subject matter expert on site management and monitoring, providing guidance and training to study teams.
Support trial close out activities, including coordination of clinical data delivery and contribution to quality sections of clinical study reports.
Facilitate timely responses to monitoring related questions from internal stakeholders, CRO partners, regulatory authorities, and ethics committees.
Ensure inspection readiness and ongoing compliance with sponsor obligations, ICH GCP guidelines, SOPs, and regulatory requirements.

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Responsibilities