Senior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics)

About this role

Job Title: Senior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics)
Job Location: Bethlehem, Pennsylvania, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Overview

• 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…