Job Overview
Provides support to CMS leads on activities related to the CMS 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 SOPs, policies and practices. Associate Centralized Monitoring Lead has particular focus on supporting the centralized team functionally reporting to leads towards solutions to clinical risks identified and working towards successful implementation of those strategies to address the issues.
Support in 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 SOP, ICH/ GCP guidelines, protocol requirements and regulatory compliance.
Review of the Study Central Monitoring Plan
Essential Functions
• Provide support to CMS leads on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operation Plan (COP) from Applications/ Analytics/ Therapeutics/ Quality perspective.;
• May perform functional lead responsibilities for assigned project deliverables for certain smaller or less complex projects from start-up to final deliverables including closeout.;
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested and note CMS specific action items.;
• Support CMS Lead to oversee the Finance related information in the study and provide inputs to EAC.;
• May manage Investigator Payment Activity from set up to close out of the study.;
• Contribute to the development and use of study management plans including Risk Assessment and Mitigation Plan, 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 CMS Lead/project team to develop monitoring strategy including monitoring triggers/thresholds, and the study specific analytics strategy, work on developing analytics based on applicable study specific plans, develop new analytics proposal as per customers demand, Perform quality reviews on the analytical output created by the team members.;
• Manage operational insight of the assigned project(s) and perform the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and discuss the action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
• Provide Inputs to CMS Lead/Project team, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;
• Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.;
• Support in managing project resources (CRAs/CTAs/Centralized monitoring team).;
• Support in performing the IP management for the assigned study to identify risk and propose mitigation plan, if any (including re-supply, re-labelling, Import/export licenses etc.).;
• Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and enable early identification of site-level risk/issue(s) and take appropriate action.;
• Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check.;
• Evaluate the quality and integrity of site practices related to the proper conduct of the study as per protocol.;
• Create and maintain relevant project documents/ trackers.;
• Ensure accurate completion and maintenance of internal systems, tracking tools and timelines.;
• Coordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.;
• Act as lead for the reviewers performing Subject Level Data Review, create plans to review the clinical data of subjects in accordance with project requirements, maintain study metrics on delivery and quality.;
• Perform regular quality checks for the data reviewed at subject-level.;
• Participate in (study) team meetings/Project kick off meetings and interaction with cross functional staff to verify information and/or triage new data issues.;
• Review site visit reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, assists with creating annotations, CRA trainings, support to conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;
• May require to mentor or coach for junior CMS staff and foster ownership and collaboration with the team.;
• Act as back up to CMS leads on assigned projects.;
• May contribute 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.;
• Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.;
• Analyze the complexity of the requirements and provide the EAC hours and turnaround time.;
• 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 qualification Req
• Master's Degree Clinical, life sciences, mathematical sciences, or related field, or nursing qualification Pref
• Minimum 4 years of relevant work experience or equivalent combination of education, training, and experience. Req
• At least 2 years of experience in clinical research field or centralized monitor role preferred. Req
• Experience level may vary based on customer specific requirements.
• Good 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.
• 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.; 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 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 and maintain effective working relationships with coworkers, managers and clients.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Ability to effectively work in team.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.; Regular sitting for extended periods of time.
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