Description
As a Senior Local Operations Manager - HemOnc at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
The Senior LOM role is a site-aligned E2E partner to streamline communication across cross-functional stakeholders throughout trial lifecycles.
Key responsibilities:
- Serve as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution.
- Intimately understand the site operational model and own relationships with critical site stakeholders to provide a voice for the site to the client's teams.
- 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.
- Ensure local/country teams meet recruitment targets with high-quality data on time and within study budget.
- Act as the primary company contact for assigned trial sites, engaging with Investigators and Site Staff throughout the life of the trial.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyse trial progress.
- Contribute to 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.
- Ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training when needed.
- Contribute to patient understanding of the protocol and patient safety by preparing country-specific informed consent.
- Ensure trial subject safety by reporting AEs/SAEs/PQCs within required reporting timelines.
- Ensure Inspection readiness by maintaining complete, accurate, and timely data and essential documents in systems utilised for trial management.
- Accountable for ensuring quality data is provided by the site and queries are resolved within expected timelines.
Requirements:
- BA/BS degree in a health or science-related field.
- 3-5+ years of trial end-to-end management experience.
- Start-up & Database Locks/Cleaning experience preferred.
- HemOnc 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.
Rewards & Benefits:
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities through structured training and career pathways.