Local Trial Management services provide local management of a clinical trial in a country or countries.
Services include operational oversight of assigned protocols from start-up through to database lock and closeout activities.
The local trial team ensures quality data and trial documents/records are compliant with the clinical trial protocol, company SOPs, ICH-GCP, and regulatory requirements.
The team collaborates with the Clinical Trial Assistant, Site Manager, and Central Trial Manager to ensure overall study delivery at the country level.
Deliverables include services rendered in accordance with sponsor SOPs, WIs, policies, and local regulatory requirements.
The team contributes to quality Site Selection through participation in site feasibility and conducts site qualification visits.
They ensure local/country teams meet recruitment targets with high-quality data on time and within study budget.
The team also maintains and updates trial management systems, analyzes trial progress, and initiates corrective and preventive actions when necessary.
Responsibilities include acting as the primary company contact for assigned trials, attending Investigator Meetings, and scheduling local/country investigator meetings.
The team drives study compliance, contributes to site level recruitment strategy, and delivers competent vendor management.
They ensure high standards for study monitoring, conduct quality local trial team meetings, and facilitate Site Manager training.
The team contributes to patient understanding of protocol and patient safety, ensures trial subject safety, and maintains inspection readiness.
The team ensures accurate finance reporting, trial delivery within budget, and compliance with local regulatory requirements.
They organize and ensure IEC/HA approvals, contribute to process initiatives, and provide input to functional areas.
The team also has experience in management and startup of complex Late Development trials.
Qualifications include a Bachelor's Degree in Life Sciences or a related field.
The team requires 2 years of local trial management or mutually agreed clinical trial experience.
Advanced qualifications include 3 to 5+ years of trial management experience, strong experience in Oncology studies, and Spanish language proficiency with advanced English language skills.
Key skills include knowledge of clinical trials, clinical trial conduct, and applicable clinical research regulatory requirements.
The team has strong written and verbal communication skills, problem-solving skills, leadership abilities, and organizational skills.
They also have good software and computer skills, including MS Office applications.
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