Site and Monitoring Health Lead

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee the effectiveness of CRO monitoring through comprehensive site risk analyses, maintaining site contacts, reviewing monitoring visit reports, conducting sponsor oversight visits, performing system and data spot checks, reviewing aggregate data, and executing periodic quality assessments.

• Prepare Sponsor Oversight Visit reports to a high standard and within designated timelines.

• Conduct risk-based evaluations of critical-to-quality factors at both study and site levels.

• Create Study Specific Oversight Plans (SSOPs) and carry out oversight activities in accordance with approved strategies.

• Identify, investigate, and resolve risks or quality issues that impact site performance and the delivery of clinical trials.

• Assist in preparing for inspections, ensuring audit readiness, and maintaining regulatory compliance.

• Foster collaborative relationships with investigators, site personnel, CRO partners, and internal cross-functional teams.

• Aid research sites, particularly those with limited clinical trial experience, in enhancing study engagement and participant recruitment.

• Collaborate with Clinical Risk and Analytics teams to evaluate site-level risks and pinpoint emerging trends.

• Facilitate oversight and trend review meetings with study teams and CRO partners.

• Implement Site and Monitoring Health strategies in accordance with ICH-GCP and relevant regulations.

• Stay informed about global and local regulatory requirements for clinical trial oversight.

⛳️ Requirements

• Extensive direct monitoring experience within a CRO or pharmaceutical organization on international clinical studies.

• Understanding of ICH-GCP, regulatory standards, and clinical trial procedures.

• Experience in supporting monitoring oversight, risk-based quality management, and the execution of clinical studies.

• Excellent communication, organizational, analytical, and problem-solving abilities.

• Proficient in Microsoft Office Suite, including Excel, Word, and PowerPoint.

• Proficient in both written and spoken English.

• Willingness to travel up to 50%, including local, regional, and international trips.

• A clinical or advanced degree is preferred, such as RN, MPH, MS, MA, MBA, or PharmD.

• Experience as a Lead CRA or in a management role is preferred.

• Experience in Phase I to Phase III clinical studies is preferred.

• Background in clinical research for prevalent and rare diseases is preferred.

• Prior experience with audits and regulatory inspections is preferred.

• Proficiency in the local language, where applicable, is preferred.

🏝️ Benefits

• Health, Vision & Dental Insurance

• Vacation/Holiday/Sick Time

• Flexible benefit portal

• Car or car allowance (applicable for certain roles)

• Flexible work arrangements

• Opportunities for growth