Local Trial Manager
3 semanas atrás
Local Trial Manager - Sponsor Dedicated role at IQVIA. Local Trial Management services provide local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through database lock and closeout activities. Services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company SOPs, ICH-GCP, and regulatory requirements.
Responsibilities- Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
- Prepare or contribute to high level budget estimates in response to Requests for Service, followed by detailed budget proposals. Ensure overall contract management, including review and approval of ESP contracts, change orders, and that services are delivered per contract.
- Act as primary company contact for the assigned trial at the country level and ensure the local/country team tracks project progress against planned timelines, monitors patient recruitment to meet target enrollment across allocated countries. This may require development of local trial procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and reports to analyze trial progress. Participate in preparation for and conduct of Health Authority inspections and internal Quality Assurance audits. Escalate corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicate study progress and issues to study management teams and business partners.
- Contribute to site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.
- Contribute to patient understanding of protocol and safety by reviewing country-specific informed consent in accordance with procedural documents/templates, SOPs, and applicable regulations.
- BA/BS degree.
- Degree in a health or science-related field.
- Minimum of 2 years of local trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of ICH-GCP, SOPs, local laws and regulations, assigned protocols and related procedures.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stays as needed.
- Excellent decision-making and strong financial management skills.
- Proficient in speaking and writing the country language and English; good written and oral communication skills as appropriate.
- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
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