Centralized Monitoring Lead – Sponsor Dedicated

About the role

The Centralized Monitoring Lead (CML) partners with the Clinical Lead and local country Site Monitors in project execution. The role provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas, monitors study start-up, manages resources, runs ongoing risk assessment through data trending and analytics and proposes mitigating actions. It leads a team of Central Monitors (CM) and Clinical Analyst Support (CAS).

Key responsibilities

• Study start-up: maintain the Clinical Operations Plan, support the iSite Pack template, KDPMP and other tools for DTE studies, set up the DTE Alert/Triggers dashboard, update SSV and Monitoring attributes on QRPM, request site monitor resources and verify training compliance and system access.
• Study initiation: coordinate site initiation activities once activation elements are resolved, and track site activation status until site initiation.
• Study maintenance: work with the Site Monitor and Clinical Lead on recruitment and compliance, perform risk assessment via data trending and analytics, manage DTE alerts and triggers, review action items, escalate significant delays to the Clinical Lead and PMA, and support the CRA on quality issues.
• Sample review of the iSite Pack, action items, site-level TMF documents and site visit reports (smaller studies); review the RM Dashboard and resolve resource assignment errors, queried requests and inactive resources.
• Manage resourcing and transition of study team members, provide training where needed, review and approve investigator payments, manage service requests and give study updates to Clinical Leads.
• Study close-out: reconcile action items, DTE alerts and study-specific triggers.

Required profile

• Bachelor's degree in life sciences or a related field, with at least 2 years of relevant clinical research experience, or an equivalent combination of education, training and experience.
• Advanced knowledge of clinical trial conduct and applicable regulatory requirements such as ICH GCP and local laws and guidelines.
• Strong leadership, communication, problem-solving, planning and time-management skills, and ability to handle conflicting priorities.
• Ability to work across cultures and geographies and to act as a mentor for Central Monitor colleagues.

Required skills

• Familiarity with clinical operations systems and software.
• Good software and computer skills, including MS Office (Word, Excel, PowerPoint).

The potential base pay range is PLN 151,200 to PLN 280,700 per year, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.