Job Overview

　　Provides leadership of the centralized monitoring team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our standard operating procedures, policies and practices. The CMM has particular focus on leading/advising the centralized team (centralized monitors and centralized monitoring assistants) towards solutions to clinical risks identified and facilitating successful implementation of those strategies to address the issues.

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

　　To provide expert support in the Centralized monitoring studies from Applications/Analytics/Therapeutics/Quality perspective

　　Essential Functions

　　• Provide oversight on clinical deliverables on assigned program/portfolios as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operation Plan (COP) from Applications/Analytics/Therapeutics/Quality perspective.;

　　• Perform functional lead responsibilities for assigned project/program deliverables for specific customers or projects/specified.;

　　• May require taking up ‘study maintenance phase’ and/or ‘study close-out phase’ end to end responsibilities for the regions assigned as defined in IQVIA SOPs.;

　　• Take up Clinical lead activities to provides oversight of unblinded monitoring procedures on a study and oversee the IP management for the assigned study/program to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).;

　　• Independently manage global studies or may be assigned at program level to oversee CMS activities on multiple studies within that program.;

　　• Lead overall customer delivery for small portfolios at an alliance level and work closely with CMS leads across studies to ensure that CMS deliverables are aligned with the customer KPIs and IQVIA SOPs.;

　　• Manage Finance related information (budget, CO etc.) for portfolio level studies within CMS and provide inputs to EAC.;

　　• Provide support at customer level for Risk Based Monitoring studies during set up phase for small studies.;

　　• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.;

　　• Oversee to the development and use of study management plans, specific tools and document templates and/or other study specific plans to evaluate the quality and integrity of the study, including complete and accurate documentation so that the project is audit ready.;

　　• Support project management team to develop monitoring strategy including monitoring triggers/thresholds, and the study specific analytics strategy.;

　　• Oversee the program/study/site/subject metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;

　　• Provide inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements & development, issue escalation, workload projections.;

　　• Oversee the added value the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.;

　　• Manage and oversee the activities of project resources (CRAs/CTAs/Centralized monitoring team).;

　　• Oversee and if needed, may conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data) to identify and mitigate project risks.;

　　• Contribute towards maintaining strong customer relationships.;

　　• Oversee and if needed perform the implementation of specific process initiatives arising out of transformation/innovation/ process re-engineering programs.;

　　• May contribute to competency development in select process areas by identifying focus areas, develop training, identify people and mechanisms to scale up the competency.;

　　• Process Quality and audit initiatives - Identify impacted areas, provide root cause and implementation of corrective and preventive action.;

　　• Ensure study/program timelines & clinical deliverables are met.;

　　• Manage feedback/escalation to monitor study/program deliverables and mitigate risk operationally.;

　　• Participate in Portfolio level initiatives.;

　　• Participate in analytics ideas brainstorming and other similar initiatives.;

　　• Act as mentor or coach for junior CMS staff and foster ownership and collaboration with the team.;

　　• Act as Subject Matter Expert to support the CMS department in delivering trainings, perform periodic review of Centralized monitoring trainings and/or identify the training needs of the team and provide inputs whenever required.;

　　• Prepare communication plan in conjunction with SME group.;

　　• Triage information to SME group and ensure that relevant information is cascaded to broader group.;

　　• Liaise with internal and external stakeholders as portfolio SME to ensure uniform process deployment, Participate in audits.;

　　• Creates annotations for studies assigned, co-ordinates CRAs trainings for big, complex studies assigned, with annotations and reports writing. Provide training for CRAs of study site visit report annotations and reports writing.;

　　• Serve as main point of study contact for CL for big, complex assigned projects when multiple SRSs are assigned.;

　　• Can be assigned for Quality Assessor, SRS Team trainer.;

　　• Can work on productivity, Delivery, Quality improvement initiatives within the department.;

　　• Stay up to date with latest developments happening in Risk Based/Centralized Monitoring industry.;

　　• Provide oversight on deliverables of the assigned projects/programs to the Technical solution Specialist (TSS) team and ensure the assigned TAT is met.;

　　• Contribute and support to the development and use of automations and implementations of tools at program level and department level initiatives.;

　　• Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).;

　　• Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).;

　　• Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.;

　　• Work in accordance of the Study Central Monitoring Plan.;

　　• Adhere to the key activities outlined in the SOW as per customer requirements.

　　Qualifications

　　• Bachelor's Degree Clinical, life sciences, mathematical sciences, or related field, or nursing/allied medical qualification, with minimum of 8 years of relevant work experience Req Or

　　• Other Medical or allied medical degree with a minimum 7 years of work experience Req

　　• Requires minimum 8 years of relevant work experience or equivalent combination of education, training and experience. Medical or allied medical degree with a minimum of 7 years of clinical trial work 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., International Conference on Harmonisation - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.

　　• Good Clinical system expertise.

　　• Strong written and verbal communication skills including good command of English language.

　　• Results and detail-oriented approach to work delivery and output.

　　• Understanding of clinical/medical data.

　　• Excellent 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.

　　• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.

　　• Effective presentation skills.

　　• Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.

　　• Ability to lead team and effectively work in team.

　　• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

　　IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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