Sr. Clinical Trial Manager

Home-based in the United States.

About the role

The Senior Local Operations Manager (LOM) role is a site-aligned end-to-end partner to streamline communication across cross-functional stakeholders throughout trial lifecycles. Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution. Intimately understands the site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams.

Responsibilities

• 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 the central study team and local stakeholders as applicable for the final selection of sites to participate in the trial.
• Ensure the local/country team meets recruitment targets with high-quality data on time and within the study budget by providing input to study-level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents, and applicable regulations. This may include development of local trial-specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Act as the 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 and promptly communicate relevant status information and issues to appropriate stakeholders.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports to analyze trial progress. Initiate corrective and preventive actions (CAPA) when the trial deviates from plans and communicate study progress and issues to study management teams and the Quality & Compliance team.
• Contribute to the site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.
• Deliver competent vendor management at the country level to support the study, including submitting requests for vendor services, supporting vendor selection, reviewing and approving site and local vendor invoices, and managing local study supply as required.
• Ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating Study Monitor (SM) training when needed (e.g., implementation of study amendments and changes in study-related processes).
• Contribute to patient understanding of protocol and patient safety by preparing country-specific informed consent in accordance with procedural documents/templates, including reviewing and managing site-specific informed consent forms in compliance with SOPs and applicable regulations.
• Ensure trial subject safety by reporting all AEs/SAEs/PQCs within required timelines and documenting them appropriately.
• Ensure 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. Escalate deviation issues to TDM/TDL and J&J Sponsor in a timely manner when issues are identified or trends are noted from MVR review.
• Accountable for ensuring quality data (accurate, valid, and complete) is provided by the site and queries are resolved within expected timelines.
• Maintain inspection readiness and therapeutic knowledge by complying with relevant training requirements.
• Work closely with SM to ensure CAPA is implemented for audits/inspections or any quality-related visits. May conduct accompanied site visits with SM if delegated by the Sponsor.
• Ensure accurate finance reporting and trial delivery within budget by adhering to finance reporting deliverables and timelines, including forecasting and proactive management of the country/local trial budget. Assist in the 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 in cooperation with the local Start-Up team, as applicable.
• May contribute as a trainer of systems/processes or provide input to functional area process initiatives, if applicable.
• Ensure full utilization through timely and accurate time reporting.
• Experience in the management and startup of complex Early Phase trials in collaboration with internal matrix clinical teams and sites, as applicable.
• Region-specific deliverables will be specified if applicable.
• Autonomy in the execution of local trial management services.
• Demonstrate depth of knowledge in local trial management services and process leadership.

Requirements

• BA/BS degree, preferably in a health or science-related field.
• 3 - 5+ years of trial end-to-end management experience.
• Start-up & Database Locks/Cleaning experience preferred.
• Solid Tumor Oncology experience required.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
• Strong IT skills in appropriate software and company systems.
• Proficient in speaking and writing the country language and English, with good written and oral communication skills.
• Legally authorized to work in the United States without requiring sponsorship for employment visa status now or in the future.

Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

Pay

$110,000 - $130,000 per year.