Centralized Monitoring Manager

Job content

Job Summary:

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 projects overall objectives to the sponsors 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 Harmonization - 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

Roles and Responsibilities

Provide oversight on clinical deliverables on assigned projects/programs as per the protocol, standard operating procedures, 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.
• Independently manage global studies or may be assigned at program level to oversee CMS activities on multiple studies within that program.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Contribute and/or 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.
• Act as point of contact for project deliverables for specific customers.
• Support project management team to develop monitoring strategy including monitoring triggers/thresholds.
• Manage and provide operational insight of the assigned project(s).
• 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.).
• Oversee and if needed contribute to developing the study/program specific analytics strategy and work on developing advanced analytics.
• Provide inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, 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 (clinical research associates/clinical trial assistants/centralized monitoring team).
• Oversee the IP management for the assigned study/program to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).
• 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.
• Take up customer lead activities to provides oversight of unblinded monitoring procedures on a study.
• May contribute to developing the study specific analytics strategy and/work on developing advanced analytics.
• Ensure complete and accurate documentation of all the study/program specific tools and templates and keep the project Audit ready.
• Contribute towards maintaining strong customer relationships.
• Contribute towards process development and improvement.
• 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.
• Act as mentor or coach for junior centralized monitoring staff.
• Process Quality and audit initiatives - Identify impacted areas, provide root cause and implementation of corrective and preventive action.
• Manage the effective transitions for Central Monitors.
• Perform quality reviews and compliance checks for the central monitors on the parameters outlined in Quality Oversight Plan. Perform spot checks and across in accordance with people manager’s quality metrics review.
• Ensure study/program timelines & clinical deliverables are met.
• Manage feedback/escalation to monitor study/program deliverables and mitigate risk operationally.
• Present and discuss significant findings and risk mitigation plan at each Quarterly FMT Meeting.
• Participate in Portfolio level initiatives.
• Acts as POC for all the SME related activities internally and externally.
• Prepare communication plan in conjunction with SME group.
• Triage information to SME group and ensure that relevant information is cascaded to broader group.
• Stay up to date with latest developments happening in Risk Based/Centralized Monitoring industry.
• Reviews reports per annotations, SOPs, guidelines etc, identifies issues and escalates the same to the CL, prepares annotations and conducts CRA trainings, conducts monthly SRS-CL calls to discuss major issues emerging from the trends noted during report review
• Can be assigned for Quality Assessor. Can work on productivity, Delivery, Quality improvement initiatives within the department.
• Serve as an expert on centralized monitoring studies to support from Applications /Analytics/ Therapeutics/ Quality perspective. Provide technical inputs in developing study specific documents, plans, applications. Support the relevant stake holders on centralized monitoring activities. Assist the relevant stake holders in developing the study management plans, tools and templates and maintain the team accountabilities. Provide resolution to the internal study team on study specific issues highlighted in the study. Acts as an expert and provides inputs to cross functional team in managing project deliverables. Provide technical support in setting up data analytics in the study. Perform periodic review of Centralized Monitoring trainings and/or liase with the training team to identify the training needs of the team and provide inputs whenever required. Support Project management team to agree Infosario Tools/Visualizations to be used for central data review, including appropriate mapping of electronic data capture with the data visualization tools. Identify and support system enhancement for IQVIA internal system/tools. Oversee the Subject level Data reviewer activities (SLDR) and Identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy. Oversee & perform trigger management compliance and i-site pack delivery. Provide technical support in conducting in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data). Act as mentor or coach for junior centralized monitoring services staff.

Desired Candidate Profile

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.