Senior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics)

IQVIA•Durham, MD

About The Position

Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc., while serving as a subject matter expert and resource for quality and compliance standards across assigned studies. Complies with relevant training requirements and maintains advanced therapeutic, operational, and regulatory knowledge applicable to assigned programs. Leads and contributes to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit reports and country feasibility reports. Collaborates with central study teams and local stakeholders as applicable for final selection of sites to participate in trials and provides strategic recommendations for site selection and performance optimization. Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing strategic input to study-level documents and independently leading/coordinating local team activities in compliance with SOPs, other procedural documents, and applicable regulations. This may require development of local trial-specific procedures and tools, recruitment planning, contingency and risk management, budget forecasting, and mitigation strategies for complex studies. Acts as primary Sponsor contact for assigned trial at the country level and serves as the local operational lead for complex studies. May attend/participate in Investigator Meetings as needed and may schedule and conduct local/country investigator meetings. Drives study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Independently identifies risks, trends, and issues and proactively initiates corrective and preventive actions (CAPA) when studies deviate from plans. Communicates study progress, risks, mitigation strategies, and key operational insights to study management teams and Quality & Compliance teams. Leads development and execution of country-level recruitment strategies and contingency planning in partnership with other functional areas to achieve clinical research targets and improve site performance. Delivers advanced vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes oversight of vendor performance, issue resolution, budget management, review and approval of site and local vendor invoices as required. As required, manages local study supplies. Ensures high standards for study monitoring by leading quality local trial team meetings and facilitating Site Manager training when needed (i.e., implementation of study amendments and changes in study-related processes). Contributes to patient understanding of protocol and patient safety by preparing country-specific informed consent documents in accordance with procedural document/templates. This includes reviewing and managing site-specific informed consent forms in accordance with SOPs, other procedural documents, and applicable regulations. Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within required reporting timelines and documented appropriately. Proactively identifies and escalates potential patient safety concerns. Ensures Inspection Readiness by maintaining complete, accurate, and timely data and essential documents in systems utilized for trial management (e.g., CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements. Proactively identifies quality trends, compliance risks, and documentation gaps across projects and drives resolution activities. Escalates significant issues to the TDM/TDL and Sponsor in a timely manner. Accountable for ensuring quality data (accurate, valid, and complete) is provided by the site and that queries are resolved within expected timelines. Provides oversight and guidance to improve site data quality and operational performance. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and maintaining advanced therapeutic area, protocol, operational, and regulatory knowledge. With focus on quality and compliance, works closely with Site Managers to ensure CAPAs are implemented for audits/inspections or any quality-related visits. May conduct accompanied site visits with Site Managers, if delegated by the Sponsor, and may provide coaching on quality-related findings and trends. Ensures accurate finance reporting and trial delivery within budget by adhering to finance reporting deliverables and timelines. This includes advanced forecasting and proactive management of country/local trial budgets, identification of financial risks, and implementation of mitigation plans. If applicable, may support negotiation of trial site contracts and budgets. Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start-Up team, as applicable. Provides guidance on complex regulatory considerations and country-specific requirements. Serves as a trainer, mentor, and subject matter expert for systems/processes and local trial management practices. Provides coaching and support to less experienced team members and contributes to onboarding and capability development activities. Leads and contributes to functional area initiatives, process improvement activities, inspection readiness activities, operational excellence projects, and implementation of new systems and processes. Full utilization by timely and accurate time reporting. Demonstrates experience in management and startup of complex Early Phase trials and projects involving matrix clinical teams, external partners, and investigational sites, as applicable. Leads country-level operational planning and execution for complex, high-priority, or high-risk studies requiring advanced trial management expertise and independent decision-making. If applicable, region-specific deliverables will be specified.

Requirements

BA/BS degree.
Degree in a health or science-related field.
3 to 5+ years of trial management experience.
Experience independently managing complex clinical trials.
Experience leading country-level trial execution activities.
Strong working knowledge of ICH-GCP, Sponsor SOPs, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
Strong IT skills in appropriate software and Sponsor systems.
Willingness to travel with occasional overnight stay away from home according to business needs.
Proficient in speaking and writing the country language and English.
Good written and oral communication skills as appropriate.

Nice To Haves

Specific therapeutic area experience may be required depending on the position.

Responsibilities

Serve as a subject matter expert and resource for quality and compliance standards across assigned studies.
Lead and contribute to quality Site Selection through participation in site feasibility.
Ensure consistent conduct of site qualification visits and appropriate follow-up of site qualification visit reports and country feasibility reports.
Collaborate with central study teams and local stakeholders for final selection of sites.
Provide strategic recommendations for site selection and performance optimization.
Ensure local/country team is meeting recruitment targets with high quality data on time and within study budget.
Provide strategic input to study-level documents and independently lead/coordinate local team activities.
Develop local trial-specific procedures and tools, recruitment planning, contingency and risk management, budget forecasting, and mitigation strategies for complex studies.
Act as primary Sponsor contact for assigned trial at the country level and serve as the local operational lead for complex studies.
Attend/participate in Investigator Meetings as needed and schedule/conduct local/country investigator meetings.
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports.
Independently identify risks, trends, and issues and proactively initiate corrective and preventive actions (CAPA).
Communicate study progress, risks, mitigation strategies, and key operational insights to study management teams and Quality & Compliance teams.
Lead development and execution of country-level recruitment strategies and contingency planning.
Deliver advanced vendor management at the country level.
Submit requests for vendor services and support vendor selection.
Oversee vendor performance, issue resolution, budget management, and review/approval of site and local vendor invoices.
Manage local study supplies as required.
Ensure high standards for study monitoring by leading quality local trial team meetings.
Facilitate Site Manager training when needed.
Contribute to patient understanding of protocol and patient safety by preparing country-specific informed consent documents.
Review and manage site-specific informed consent forms.
Ensure trial subject safety by reporting AEs/SAEs/PQCs within required reporting timelines.
Proactively identify and escalate potential patient safety concerns.
Ensure Inspection Readiness by maintaining complete, accurate, and timely data and essential documents in systems utilized for trial management.
Proactively identify quality trends, compliance risks, and documentation gaps across projects and drive resolution activities.
Escalate significant issues to the TDM/TDL and Sponsor in a timely manner.
Ensure quality data (accurate, valid, and complete) is provided by the site and that queries are resolved within expected timelines.
Provide oversight and guidance to improve site data quality and operational performance.
Comply with relevant training requirements and maintain advanced therapeutic area, protocol, operational, and regulatory knowledge.
Work closely with Site Managers to ensure CAPAs are implemented for audits/inspections or any quality-related visits.
Conduct accompanied site visits with Site Managers, if delegated by the Sponsor, and provide coaching on quality-related findings and trends.
Ensure accurate finance reporting and trial delivery within budget.
Manage country/local trial budgets, identify financial risks, and implement mitigation plans.
Support negotiation of trial site contracts and budgets, if applicable.
Keep the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals.
Provide guidance on complex regulatory considerations and country-specific requirements.
Serve as a trainer, mentor, and subject matter expert for systems/processes and local trial management practices.
Provide coaching and support to less experienced team members and contribute to onboarding and capability development activities.
Lead and contribute to functional area initiatives, process improvement activities, inspection readiness activities, operational excellence projects, and implementation of new systems and processes.
Ensure timely and accurate time reporting.
Demonstrate experience in management and startup of complex Early Phase trials and projects.
Lead country-level operational planning and execution for complex, high-priority, or high-risk studies.