IQVIA
Life Sciences
AssociateCentralizedMonitor
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Associate Centralized Monitor at IQVIA. Skills: Centralized monitoring, Site communication, Operational insight. Complete role-specific training. Provide study level administrative support”
What You'll Achieve.
Meeting quality metrics; Meeting timeline metrics
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
Minimum of 1 year relevant experience, Good knowledge of applicable clinical research regulatory requirements, Proficient in Clinical Systems, Experience of managing global phase trials, Written and verbal communication skills, Good command of English language, Good software and computer skills, Microsoft Office applications, Ability to establish and maintain effective working relationships, Good data entry skills
Nice to Have
Graduate/Post Graduate in Life Sciences or related field, 2 to 5 years of work experience, Equivalent combination of education, training and experience, Experience level may vary based on customer specific requirements, Results and detail-oriented approach to work delivery and output, Good problem-solving skills, Good planning, time management and prioritization skills, Attention to detail and accuracy in work, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Telecommunication skills
What You'll Do.
Complete role-specific training
Provide study level administrative support
Prepare status reports
Create study trackers
Maintain study trackers
Follow up for outstanding issues
Update and maintain systems
Drive tracking compliance
Perform delegated activities
Assist in preparation of i-site pack
Pull associated reports
Perform centralized monitoring activities
Evaluate quality and integrity
Prepare i-site pack for sites
Interact with sites/CRA
Follow-up of missing data
Follow-up of pending queries
Follow-up of SDV backlog
Follow-up of visit schedule
Establish and maintain project/site communication
Assist leads in maintenance of internal systems
Assist leads in maintenance of databases
Assist leads in maintenance of tracking tools
Assist leads in maintenance of project plans
Manage operational insight
Complete study/site metrics trending
Review clinical study alerts
Triage clinical study alerts
Action clinical study alerts
Monitor COP compliance
Perform Subject Level Data Review
Determine overall accuracy
Review patient information
Perform Study specific analytics
Perform assigned access management tasks
Process access requests
Follow up with relevant vendors
Assign catalog task to process associates
Act as backup for Centralized Monitors
Act as backup for Sr. Centralized Monitors
Provide support to technical solution specialist
Facilitate early identification of site-level risk
Facilitate early identification of site-level issue
Monitor site performance
Make recommendations for timely corrective actions
Review effectiveness of recommended actions
Take appropriate additional actions
Review Study Central Monitoring Plan
Adhere to key activities outlined in SOW
How You'll Work.
Team & Collaboration
Effective project communication; Effective site communication; Working relationships with coworkers; Working relationships with managers; Working relationships with clients
Communication Scope
Written communication; Verbal communication; English language; Telecommunication
Process & Methodology
Project timelines, Project plans
Full Job Description
**Job Overview** Provide project related assistance to assigned project teams. Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements. Meeting quality and timeline metrics. **Essential Functions** * Complete appropriate role-specific training to perform job duties. * Under supervision, provides study level administrative support to the clinical study management team (examples of such tasks include, but not limited to running system reports, preparing and distributing status reports, creating and maintaining study trackers, follow-up for outstanding issues, etc.). * Assist in updating and maintaining systems within project timelines/plans and driving tracking compliance in various systems to enable credible data for analysis. * Perform the activities as per the task list delegated by CMS leads. * Assist CMs in the preparation of i-site pack for their respective sites and countries for assigned studies, by pulling associated reports. * Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines. * Prepare i-site pack for respective sites and countries for assigned studies. * Interact with sites/CRA and follow-up of missing data, pending queries, SDV backlog, visit schedule, PD, etc. * Establish and maintain effective project/site communication. * Assist leads in maintenance of internal systems, databases, tracking tools and project plans. * Manage the operational insight of the assigned sites/studies 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.). * Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & e
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