Senior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics)

About the role

iQVIA is hiring a Senior Local Trial Manager in Durham, NC, dedicated to a sponsor and covering multiple therapeutic areas. The role acts as the primary sponsor contact at country level and leads country-level operations for complex studies, driving quality, compliance, recruitment and budget control.

Key responsibilities

• Lead site selection and qualification, coordinate with central teams and give strategic recommendations on site performance.
• Ensure recruitment targets are met on time and within budget, including recruitment planning, risk management and budget forecasting.
• Maintain and update trial management systems, identify risks and trends and initiate CAPA when studies deviate from plan.
• Manage country-level vendor relationships, including vendor selection, performance oversight, invoice review and approval, and manage local study supplies.
• Prepare country-specific informed consent documents and ensure AEs/SAEs/PQCs are reported on time.
• Keep inspections ready by maintaining accurate data and documents in CTMS and eTMF/IF, and escalate significant issues to the TDM/TDL and sponsor.
• Ensure quality data from sites, resolve queries on time, and coach site managers on quality findings.
• Support site contracts and budgets where applicable, and obtain IEC/HA approvals with the local start-up team.
• Train and mentor team members, contribute to process improvement and inspection readiness projects, and report time accurately.

Required profile

• BA/BS degree, preferably in a health or science-related field.
• 3 to 5+ years of trial management experience, including independently managing complex clinical trials and leading country-level execution.
• Experience managing complex early phase trials and matrix clinical teams, and leading operational planning for high-priority or high-risk studies.
• Willingness to travel occasionally, including overnight stays.
• Proficiency in the country language and English, with good written and oral communication.

Required skills

• Strong working knowledge of ICH-GCP, sponsor SOPs, local laws and regulations, and assigned protocols.
• Strong IT skills in appropriate software and sponsor systems.