Senior Local Operations Manager - Oncology Solid Tumor - Home Based (US)

About the Role The Senior Local Operations Manager (LOM) for Oncology Solid Tumor will be a site-aligned end-to-end partner, coordinating cross-functional trial lifecycles and serving as the primary point of contact for investigative sites. Based remotely in the US, this role drives site feasibility, recruitment targets, data quality, regulatory readiness, and budget management while ensuring compliance and patient safety across trials. What You'll Do

• Serve as a site-aligned end-to-end partner to streamline communication across cross-functional stakeholders throughout trial lifecycles.
• Act as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution.
• Develop deep understanding of site operational model and own relationships with critical site stakeholders to provide a voice for the site to client teams.
• Contribute to quality Site Selection through site feasibility activities, ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit reports and country feasibility reports.
• Collaborate with central study team and local stakeholders for final site selection to participate in the trial.
• Ensure local/country team meets recruitment targets with high-quality data on time and within study budget by providing input to study-level documents and leading/coordinating local team activities compliant with SOPs and regulations; may develop local trial procedures, recruitment planning, contingency and risk management, and budget forecasting.
• Act as primary company contact for assigned trial sites, engaging with Investigators and Site Staff throughout the life of the trial.
• Focus on investigator engagement through timely follow-up with sites; promptly communicates relevant status information and issues to appropriate stakeholders.
• Drive study compliance by maintaining/updating trial management systems, using study tools and management reports to analyze trial progress; initiate CAPA when the trial deviates and communicate progress to study management teams and Quality & Compliance.
• Contribute to site-level recruitment strategy and contingency planning/implementation in partnership with other functional areas to achieve recruitment targets.
• Manage vendor relationships at the country level; may submit requests for vendor services and support vendor selection; reviewing and approving site and local vendor invoices; may manage local study supply.
• Ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training when needed (e.g., changes in study-related processes).
• Contribute to patient understanding of protocol and patient safety by preparing country-specific informed consent and reviewing/managing site-specific informed consent forms.
• Ensure trial subject safety by timely reporting of AEs/SAEs/PQCs and appropriate documentation.
• Maintain inspection readiness by keeping complete data and essential documents in systems (CTMS/eTMF/IF) and escalating deviation issues to TDM/TDL and Sponsor as needed.
• Accountable for quality data provided by the site and timely resolution of queries.
• Maintain inspection readiness through training requirements and therapeutic knowledge development; may conduct accompanied site visits with SM if delegated.
• Ensure CAPA is implemented for audits/inspections or quality-related visits; may conduct accompanied site visits with SM if delegated.
• Ensure accurate finance reporting and budget delivery by adhering to reporting deliverables and timelines; forecast country/local budgets and participate in site contract/budget negotiations when applicable.
• Maintain regulatory compliance by organizing IEC/HA approvals in cooperation with Start Up team as applicable.
• May contribute as a trainer of systems/processes or provide input to process initiatives, if applicable.
• Ensure full utilization through timely and accurate time reporting.
• Leverage experience in the management and startup of complex Early Phase trials with internal matrix clinical teams and sites, as applicable.
• Regional deliverables may be specified; demonstrate autonomy and depth of knowledge in local trial management services and process leadership. What We're Looking For
• BA/BS degree; degree in a health or science-related field.
• 3-5+ years of end-to-end trial management experience; startup and database locks/cleaning experience preferred.
• Solid Tumor Oncology experience is required.
• Strong working knowledge of ICH-GCP, SOPs, local laws and regulations, assigned protocols and protocol-specific procedures.
• Strong IT skills in appropriate software and company systems.
• Proficient in speaking and writing the country language and English; good written and oral communication skills. Nice to Have
• Experience in management and startup of complex Early Phase trials with internal matrix teams and sites (as applicable).
• Region-specific deliverables may be specified. Compensation & Benefits
• Not disclosed in posting.