Job Overview

Manage the execution of assigned clinical studies from initiation through closeout. Ensure clinical study management and project deliverables are on time and in accordance with standard operating procedures (SOPs), policies, and practices.

Provide project-related support and assistance across multiple projects, sites, and teams, and review structured clinical data output with access to medical charts. Ensure work is conducted per SOPs, policies, Good Clinical Practices (GCP), and applicable regulatory requirements. Adhere to protocol, ensure overall completeness and readiness of supplied patient information for the next level of review, and follow metrics and timelines.

Facilitate efficient and effective review of Site Visit Reports, ensuring consistent standards of implementation for quality to meet or exceed standards. Ensure subject safety, data integrity, issue escalation, and timely feedback in compliance with IQVIA SOPs, International Conference on Harmonization - Good Clinical Practice (ICH GCP) guidelines, protocol requirements, and regulatory compliance.

Develop and use study management plans and/or risk-based monitoring tools and templates to evaluate the quality and integrity of the study. Support project management teams in developing monitoring strategies, including monitoring triggers/thresholds. Manage operational insights of assigned projects and complete study/site metrics trending.

Essential Functions

• Manage assigned sites and perform Subject Level Data Review independently or in a dual role.
• Perform remote monitoring visits for assigned sites.
• Investigate Subject Level Data Review with clinical sites to determine overall accuracy and readiness for next level review.
• Perform study-specific analytics and contribute to developing new analytics proposals.
• Manage operational insights of assigned sites/studies and complete study/site metrics trending.
• Provide inputs to clinical study teams, key decision makers, and internal team members for continuous process improvements and issue escalation.
• Identify value adds from centralized review and remote monitoring, providing inputs to relevant stakeholders.
• Support CMS leads in overseeing clinical deliverables on assigned projects.
• Collaborate and support project resources (CRAs/CTAs/Centralized Monitoring team).
• Ensure complete and accurate documentation of site-specific tools and templates.
• Perform centralized monitoring activities and evaluate quality and integrity per protocol, SOPs, and guidelines.
• Maintain internal systems, databases, and tracking tools/reports for site-specific information.
• Manage triggers and prepare i-site packs for respective sites and countries.
• Act as backup for relevant stakeholders within the project team.
• Conduct periodic review of site-level KRIs and historic site performance.
• Monitor site performance and recommend corrective actions.
• Review effectiveness of recommended actions and take additional actions if needed.
• Work according to the Study Central Monitoring Plan.
• Establish and maintain effective project/site-level communications with stakeholders.
• Provide mentorship to Associate Central Monitors.
• Review reports, identify issues, and escalate to the Clinical Lead.
• Act as a technical solution specialist (TSS) point of contact for project teams/internal stakeholders.
• Analyze requirements complexity and provide EAC hours and turnaround time.
• Review the Study Central Monitoring Plan.
• Attend Kick-Off meetings, weekly team meetings, and client meetings as needed.
• Adhere to key activities outlined in the SOW as per customer requirements.

Qualifications

• Bachelor's degree in clinical, life sciences, mathematical sciences, or related field, or nursing qualification.
• Minimum of 2 years of relevant work experience or equivalent combination of education, training, and experience.
• Freshers with Medical or Allied medical degrees are welcome.
• Experience in clinical research preferred.
• Advanced knowledge of clinical trial conduct and applicable clinical research regulatory requirements (ICH GCP and relevant local laws).
• Good clinical system expertise.
• Strong written and verbal communication skills, including good command of English.
• Results and detail-oriented approach to work delivery and output.
• Understanding of clinical/medical data.
• Good motivational, influencing, and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• In-depth therapeutic and protocol knowledge.
• Strong organizational and problem-solving skills.
• Effective presentation skills.
• Demonstrated ability to deliver results to quality and timeline metrics.
• Ability to work across cultures and geographies with high awareness and understanding of cultural differences.
• Maintain effective working relationships with coworkers, managers, and clients.

This is a remote/WFH opportunity

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $57,000.00 - $95,000.00. 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.