Job Overview
Lead the execution of Centralized monitoring activities at multiple sites and studies from initiation through to closeout. Ensure that completion of work, clinical study management and project deliverables are on time and is in accordance with SOPs, policies and Good Clinical practices and applicable regulatory requirements. To provide CMS related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts. Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and support the CMS leads in defining the metrics and timelines. 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 SOP, ICH/ GCP guidelines, protocol requirements and regulatory compliance. Periodic review of site level KRIs and historic site performance according to Central Monitoring Plan.
Essential Functions
Review Central Monitoring KRIs, Endpoint Analyses, Quality Tolerance Limits (QTLs), and other analyses on an ad hoc basis or as outlined in the study-specific Central Monitoring Plan (CMP)
Minimum 1.5 yrs of Central Monitoring or Risk-based quality management Experience
Collaborate effectively with study team
Excellent Communication skills
Manage assigned sites and perform Subject Level Data Review independently for multiple studies, if required perform with both responsibilities as dual role.;
Perform remote monitoring visits for assigned sites as per requirement.;
Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;
Perform Study specific analytics based on applicable study specific plans.; Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value and/or work on developing advanced analytics.;
Manage the operational insight of the assigned project(s) and complete the study/site 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, issue escalation, workload projections.;
Adhere to customer roles and responsibilities or as activities defined per Scope Of Work
Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;
Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;
Provide Mentorship to central monitors and CMA centralized monitoring associates.;
Act as subject matter expert on one or more CMS specific activities/deliverables.;
May lead study level efforts like automation of ISP, process enhancements, act as a POC for internal CM team and provide advice to the team.;
Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).;
Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.;
Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.;
Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.;
Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;
Perform the activities delegated and/or act as back up for/to relevant stakeholders including leads within the project team.;
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.;
Establish and maintain effective project/ site level communications with relevant stakeholders.;
Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;
Review daily reports and prepare weekly/monthly reports and present it to Leadership Team, need to mentor and provide appropriate trainings to associates and attend study team meetings as needed or requested.;
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.;
Review of the Study Central Monitoring Plan
Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
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
Minimum of 3 years of relevant work experience or equivalent combination of education, training and experience.
Experience in clinical research field preferred. Pref
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, 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 the appropriate quality and timeline metrics.
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.
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
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