Overview
Centralized Monitoring Lead Sponsor Dedicated Jobs in Centurion, South Africa at IQVIA
Position: Â Centralized Monitoring Lead Sponsor Dedicated)
Primary Function:
Centralized Monitoring Lead (CML)partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites, and therapeutic areas. Monitors study start-up, manages resources, performs ongoingrisk assessmentthrough data trending and analytics, and proposes potential mitigating actions in a timely fashion. Leads a team of Central Monitors (CM) and Clinical Analyst Support (CAS).
Roles & Responsibilities:
Study Start-up
Maintains Clinical Operations Plan. Supports development of iSite Pack template, KDPMP, and other tools/templates for DTE studies. Works with relevant stakeholders for set-up and activation of DTE Alert/Triggers dashboard.
Ensures the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM. Requests site monitor resources for site selection visits. Verifies training compliance and system access for the site management team involved during the study start-up.
LCA or designee informs the monitor of all site activation critical elements that should be obtained to ensure the successful and efficient conduct of the site selection activity.
Tracks site activation related critical elements on an ongoing basis before Site Initiation and keeps CL and Start-up Lead updated about the status of the site activation.
Study Initiations
Requests monitor resource for site initiation and site monitoring. Verifies training compliance and system access for the site management team (CRA, CM, and CAS) involved in the study site initiations.
Coordinates with all stakeholders to start the site initiation activities once all site activation critical elements are obtained/resolved.
Study Maintenance
Closely works with Site Monitor and CL during the study execution phase withrespectto recruitment and compliance with the Clinical Operation Plan. Performs ongoingrisk assessmentthrough data trending and analytics and proposes potential mitigating actions in a timely fashion. Supports CRA in management of Quality issues.
Manages DTE Alerts and other study-specific triggers. Reviews the status of action items and follows up with relevant team members for closure of action items. Escalates to Clinical Lead and PMA in case of significant delays in closure of action items if required.
Sample review of iSite Pack (DTE studies), closed and open action items, Site Level documents on TMF.
As applicable, reviews Site Visit reports (for smaller studies with less than 20 reports per month).
Reviews the RM Dashboard and resolves any items that need attention (i.e., Resource Assignment Errors, Queried Requests, and Inactive Resources Still Assigned).
Manages resourcing and transition of study team members during the execution phase. Provides training to Site Monitor, Central Monitor, and Clinical Analyst Support if required.
Reviews and approves Investigator Payments.
Reviews and manages service requests received by CCO staff.
Provides study updates to Clinical Leads as per study requirements.
Study Closeout
Reconciles action items, DTE alerts, and study-specific triggers.
REQUIRED KNOWLEDGE,
SKILLS AND ABILITIES
Bachelor’s degree in life sciences or related field and min 2 years with relevantclinical researchexperience; or equivalent combination ofeducation, training, and experience.
Adv…
Title: Centralized Monitoring Lead Sponsor Dedicated
Company: IQVIA
Location: Centurion, South Africa
Category: Healthcare, Research/Development
