Site Report Specialist

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 projects 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 and historic site performance according to Central Monitoring Plan and enable Early identification of site-level risk/issue(s) and take appropriate action.;
• Act as point of contact for assigned deliverables for specific customer or projects/specified.;
• Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check.;
• Evaluate the quality and integrity of site practices related to the proper conduct of the study as per protocol and adherence to applicable regulations.;
• Establish and maintain effective project/ site level communications with relevant stakeholders.;
• Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.;
• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.;
• Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.;
• Process Quality and audit initiatives.;
• Identify impacted areas under CMS purview, provide root cause and implementation of corrective and preventive action.;
• Ensure accurate completion and maintenance of internal systems, tracking tools and timelines.;
• Coordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.;
• Act as lead for the reviewers performing Subject Level Data Review, create plans to review the clinical data of subjects in accordance with project requirements, maintain study metrics on delivery and quality. Perform regular quality checks for the data reviewed at subject-level.;
• Participate in (study) team meetings/Project kick off meetings and interaction with cross functional staff to verify information and/or triage new data issues.;
• 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.;
• Can be assigned as Quality Assessor.;
• Act as mentor or coach for junior CMS staff and foster ownership and collaboration with the team.;
• Act as Subject Matter Expert to support the CMS department in delivering trainings, perform periodic review of Centralized monitoring trainings and/or identify the training needs of the team and provide inputs whenever required.;
• Act as mentor or coach for Technical solution Specialist (TSS).;
• Distribution of the task to the TSS team members based on their availability
• Foresee Risk associated with Project deliverables and prepare contingency Risk Mitigation plans.;
• Submit/present detailed analysis note of the new request to Management/Requestor.;
• Agree on TAT to delivery to project teams/customers, providing oversight on key clinical/TSS deliverables related to Management.;
• 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
• Adhere to the key activities outlined in the SOW as per customer requirements.

Qualifications
• Bachelor's Degree Bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, nursing qualification or allied medical degree.

Req Or
• Requires minimum of 5 years of relevant experience or Medical degree with a minimum 4 years of clinical trial 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.
• Good motivational, influencing, negotiating and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• In depth therapeutic and protocol knowledge.
• Strong organizational, problem solving and decision-making 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 and maintain effective working relationships with coworkers, managers and clients.
• To lead team and effectively work in team