Assoc Site Report Specialist

Role:  Assoc Site Report Specialist/Site Report Specialist
Total

Experience:

3+yrs exp into CRA
Work location & Mode : PAN India
-Homebased
Must Have

Skills:

On site Monitoring

Job Overview
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 project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our standard operating procedures, policies and practices. The CML 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 Harmonisation - Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance.
To provide expertise support in the Centralized monitoring studies from Applications, Analytics and Therapeutics or Quality perspective.
Essential Functions

• Provide oversight 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.;

• Independently perform functional lead responsibilities for assigned project deliverables for specific customers or projects/specified from start-up to final deliverables including closeout.;

• May require taking up ‘study maintenance phase’ and/or ‘study close-out phase’ end to end responsibilities for the regions assigned as defined in IQVIA SOPs.;

• May require to take up Clinical lead activities to provides oversight of unblinded monitoring procedures on a study and oversee the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).;

• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested and note CMS specific action items.;

• Manage Finance related information (budget, CO etc.) for the assigned studies within CMS and provide inputs to EAC.;

• 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 project management team to develop monitoring strategy including monitoring triggers/thresholds and the study specific analytics strategy.;

• Develop new and/or advanced analytics proposal as per customers demand, perform quality reviews on the analytical output created by the associates, support CMS leads in managing the analytics delivery, participate in internal and external meetings to present analytics output, support CMS leads in audits and inspection as needed.;

• Manage and monitor operational insight of the assigned project(s) and complete/oversee 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 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.;

• Manage project resources (CRAs/CTAs/Centralized monitoring team).;

• Conduct periodic review of site level KRIs…