Centralized Monitoring Lead- Sponsor Dedicated

IQVIA; Warszawa; On-site; PLN 151,000 - 281,000; Full time

Job summary

IQVIA LLC in Warszawa seeks a Centralized Monitoring Lead (CML) to partner with the Clinical Lead and country Site Monitors in project execution, providing centralized support to monitoring visits and site management across protocols and therapeutic areas. You will oversee study start-up, resource planning, and risk assessment through data analytics while mentoring Central Monitors and CAS.

This role requires strong leadership, English communication, and a detail-oriented, results-driven

Qualifications

• Bachelor’s degree in life sciences or related field and min 2 years with relevant clinical research experience; or equivalent combination of education, training and experience.
• Advanced knowledge of clinical trial conduct and regulatory requirements (ICH GCP, local laws) in clinical trial operations.
• Familiarity with systems and software used in clinical operations.
• Strong leadership and communication skills; English proficiency.

Responsibilities

• Support study start-up activities and development of templates/tools for DTE studies.
• Coordinate with stakeholders to initiate site activation and start-up activities.
• Monitor study progress, perform risk assessment via data analytics, and propose mitigating actions.
• Lead Central Monitors and Clinical Analyst Support, ensuring quality and timely study updates.

Skills

Clinical trial conduct

Leadership

English communication

Time management

Problem solving

Attention to detail

MS Office

Cross-cultural collaboration

Mentoring

Education

Bachelor’s degree in life sciences

Tools

Clinical operations software

Job description

Primary Function: Centralized Monitoring Lead (CML) partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Leads team of Central Monitors (CM) and Clinical Analyst Support (CAS).

Roles & Responsibilities:

• Study Start-up: Maintains Clinical Operations Plan. Supports development of iSite Pack template, KDPMP and other tools/templates for DTE studies. Works with relevant stakeholders for set-up and activation of DTE Alert/Triggers dashboard. Ensure the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM. Request site monitor resources for site selection visits. Verifies training compliance and system access for the site management team involved during the study start-up. LCA or designee informs the monitor of all site activation critical elements that should be obtained to ensure the successful and efficient conduct of the site selection activity. Tracks site activation related critical elements on an ongoing basis before Site Initiation and keeps CL and Start-up Lead updated about the status of the site activation.
• Study Initiations: Requests monitor resource for site initiation and site monitoring. Verifies training compliance and system access for the site management team (CRA, CM and CAS) involved in the study site initiations. Coordinates with all stakeholders to start the site initiation activities once all site activation critical elements are obtained/resolved.
• Study Maintenance: Closely works with Site Monitor and CL during study execution phase with respect to recruitment and compliance to Clinical Operation Plan. Perform ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Supports CRA in management of Quality issues. Manages DTE Alerts and other study specific triggers. Reviews status of action items and follow-ups with relevant team members for closure of action items. Escalates to Clinical Lead and PMA in case of significant delays in closure of action items if required. Sample review of iSite Pack (DTE studies), closed and open action items, Site Level documents on TMF. As applicable reviews Site Visit reports (for smaller studies with less than 20 reports per month). Review the RM Dashboard and resolve any items that need attention (i.e., Resource Assignment Errors, Queried Requests, and Inactive Resources Still Assigned). Manages resourcing and transition of study team members during execution phase. Provides training to Site Monitor, Central Monitor and Clinical Analyst Support if required. Reviews and approves Investigator Payments. Review and manages services requests received by CCO staff. Provides study updates to Clinical Leads as per study requirements.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor's degree in life sciences or related field and min 2 years with relevant clinical research experience; or equivalent combination of education, training and experience.
• Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Familiarity with related systems and software’s utilized in clinical operations.
• Strong leadership skills.
• Strong written and verbal communication skills including good command of English language.
• Results and detail-oriented approach to work delivery and output.
• Good problem solving skills.
• Good planning, time management and prioritization skills.
• Ability to handle conflicting priorities.
• Attention to detail and accuracy in work.
• Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
• Act as a mentor for Central Monitor colleagues.

The potential base pay range for this role, when annualized, is zł151,200.00 - zł280,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.