Centralized Monitoring Lead - sponsor dedicated Poland (Hybrid/Home-based)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The company focuses on accelerating the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.

• Bachelor's degree in clinical, life sciences, mathematical sciences, nursing qualification, or allied medical degree.
• Minimum 5 years of relevant experience or Medical degree with minimum 4 years clinical trial experience or equivalent combination of education, training, and experience.
• Advanced knowledge of clinical trial conduct and applicable clinical research regulatory requirements including ICH GCP and relevant local laws.
• Good clinical system expertise.
• Strong written and verbal communication skills with good command of English.
• Results and detail-oriented approach.
• Understanding of clinical/medical data.
• Good motivational, influencing, negotiating, and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• In-depth therapeutic and protocol knowledge.
• Strong organizational, problem-solving, and decision-making skills.
• Demonstrated ability to deliver results to quality and timeline metrics.
• Effective presentation skills.
• Ability to work across cultures and geographies with awareness of cultural differences.
• Leadership skills to lead and work effectively in a team.

• Provide leadership of the centralized monitoring team in partnership with project and clinical leads and other functional teams to achieve project objectives per contract while optimizing speed, quality, and cost.
• Lead and advise the centralized team towards solutions to clinical risks and facilitate implementation of strategies to address issues.
• Facilitate efficient and effective review of Site Visit Reports and assure consistent quality standards.
• Ensure subject safety, data integrity, issue escalation, and timely feedback in compliance with IQVIA SOPs, ICH GCP guidelines, protocol requirements, and regulatory compliance.
• Provide expertise support in Centralized monitoring studies from Applications, Analytics, Therapeutics, or Quality perspectives.
• Perform functional lead responsibilities for assigned project deliverables from start-up to closeout.
• Attend Kick-Off, weekly team, and client meetings and note CMS specific action items.
• Manage finance-related information and investigator payment activities for assigned studies.
• Contribute to development and use of study management plans including Risk Assessment and Mitigation Plan.
• Support project management in developing monitoring and analytics strategies.
• Develop analytics proposals, perform quality reviews, support audits and inspections.
• Manage and monitor operational insight and study/site metrics trending.
• Provide inputs to clinical study team and key decision makers for process improvements and issue escalation.
• Manage project resources including CRAs, CTAs, and centralized monitoring team.
• Conduct periodic review of site level KRIs and historic site performance to identify risks and take action.
• Act as point of contact for assigned deliverables.
• Monitor operational triggers, key data points, and perform regular quality checks.
• Evaluate quality and integrity of site practices per protocol and regulations.
• Establish and maintain effective project/site level communications.
• Oversee site management activities and evaluate study quality and integrity.
• Coordinate cross-functional project teams to support milestones and manage study issues.
• Ensure complete and accurate documentation and audit readiness.
• Lead Subject Level Data Review and maintain study metrics on delivery and quality.
• Participate in team meetings and verify information or triage new data issues.
• Review reports, identify issues, escalate to Clinical Lead, prepare annotations, conduct CRA trainings, and hold monthly stakeholder calls.
• Act as Quality Assessor and mentor or coach junior CMS staff and Technical Solution Specialists.
• Distribute tasks to TSS team members based on availability.
• Foresee project risks and prepare contingency risk mitigation plans.
• Submit detailed analysis notes of new requests to management.
• Agree on TAT for delivery to project teams/customers and oversee key clinical/TSS deliverables.
• Monitor site performance and recommend corrective actions; review effectiveness and take additional actions if needed.
• Work in accordance with Study Central Monitoring Plan and adhere to key activities outlined in SOW as per customer requirements.

IQVIA maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements, misrepresentations, or material omissions during recruitment will result in disqualification or termination of employment in accordance with applicable law.