Overview
As a Senior Clinical Trial Manager, you will join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. This role involves operational oversight of assigned protocols at the country level from start-up through to database lock and closeout activities.
Responsibilities
* Adhere to applicable sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
* Ensure compliance with relevant training requirements.
* Contribute to quality site selection through participation in site feasibility assessments, ensuring consistent conduct of pre-trial visits, and follow-up of reports. Collaborate with the central study team for final site selection.
* Ensure local/country team meets recruitment targets with high-quality data on time and within budget by providing input to study documents and leading local activities in compliance with SOPs and regulations. Develop local procedures and tools as needed.
* Act as the primary company contact for the trial at the country level, participate in investigator meetings, and possibly conduct local meetings.
* Drive study compliance through trial management systems, analyze trial progress, and initiate corrective actions when deviations occur.
* Contribute to site-level recruitment strategies and contingency planning to meet research targets.
* Manage vendor relationships at the country level, review invoices, and manage local study supplies.
* Maintain high standards for study monitoring, conduct quality team meetings, and facilitate training.
* Prepare and review country-specific informed consent forms, ensuring patient safety and compliance.
* Report adverse events (AEs/SAEs/PQCs) within required timelines and document appropriately.
* Maintain inspection readiness by ensuring complete, accurate data and documentation, and escalate issues as needed.
* Ensure compliance with local regulations for IEC/HA approvals.
* Contribute as a mentor or process champion as needed.
* Report time accurately and timely.
* Experience in managing and initiating complex early-phase trials is preferred.
Qualifications
* BA/BS degree in health or science-related field.
* 3 to 5+ years of trial management experience.
* Knowledge of ICH-GCP, SOPs, local laws, and protocols.
* Strong IT skills and willingness to travel.
* Proficient in the local language and English, with good communication skills.
What ICON Can Offer
We prioritize diversity, high performance, and talent development. Benefits include various leave entitlements, health insurance, retirement plans, global assistance programs, life assurance, and flexible benefits tailored to your country.
Visit our careers website to learn more: https://careers.iconplc.com/benefits
ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment and reasonable accommodations as needed. If interested, apply regardless of whether you meet all requirements, as you may be the right fit for this or other roles at ICON.
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