Senior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics)

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.

Responsibilities

• Comply with relevant training requirements and maintain advanced therapeutic, operational, and regulatory knowledge applicable to assigned programs.
• Lead and contribute 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.
• Collaborate with central study teams and local stakeholders for final selection of sites to participate in trials and provide strategic recommendations for site selection and performance optimization.
• Ensure the local/country team meets 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 and applicable regulations.
• Develop local trial-specific procedures and tools, recruitment planning, contingency and risk management, budget forecasting, and mitigation strategies for complex studies.
• Act as the primary Sponsor contact for assigned trials 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 to analyze trial progress.
• Independently identify risks, trends, and issues and proactively initiate corrective and preventive actions (CAPA) when studies deviate from plans.
• 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 in partnership with other functional areas to achieve clinical research targets and improve site performance.
• Deliver advanced vendor management at the country level to support the study, including oversight of 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 and facilitating Site Manager training when needed.
• Prepare country-specific informed consent documents in accordance with procedural documents/templates and manage site-specific informed consent forms.
• Ensure trial subject safety by reporting all AEs/SAEs/PQCs within required timelines and documenting appropriately; proactively identify and escalate potential patient safety concerns.
• Ensure inspection readiness by maintaining complete, accurate, and timely data and essential documents in trial management systems (e.g., CTMS and eTMF/IF) according to expectations and archiving retention requirements.
• 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.
• Maintain inspection readiness and advanced therapeutic area, protocol, operational, and regulatory knowledge through compliance with relevant training requirements.
• 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.
• Ensure accurate finance reporting and trial delivery within budget by adhering to finance reporting deliverables and timelines, including advanced forecasting and proactive management of country/local trial budgets.
• Support negotiation of trial site contracts and budgets, if applicable.
• Organize and ensure IEC/HA approvals in cooperation with the local Start-Up team, as applicable; 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.
• 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 full utilization through timely and accurate time reporting.
• Demonstrate experience in management and startup of complex Early Phase trials and projects involving matrix clinical teams, external partners, and investigational sites.
• Lead country-level operational planning and execution for complex, high-priority, or high-risk studies requiring advanced trial management expertise and independent decision-making.

Requirements

• BA/BS degree; degree in a health or science-related field preferred.
• 3 to 5+ years of trial management experience, including experience independently managing complex clinical trials and leading country-level trial execution activities.
• Specific therapeutic area experience may be required depending on the position.
• 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.

Pay

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.