Offer summary

Qualifications:

Bachelor's degree in healthcare or a scientific discipline., 2-3 years of experience leading local, regional, or global teams., 2-3 years of clinical trial project management experience., Knowledge of ICH-GCP regulations and local regulatory environments..

Key responsibilities:

Manage and coordinate the conduct of clinical trials from start-up to close-out.

Partner with global and local teams to ensure study progress and delivery.

Oversee site selection, training, and vendor activities at the country level.

Monitor study timelines, budgets, and quality metrics to ensure compliance.

Job description

As Local Trial Manager (LTM) you will be responsible for running internationalglobal studies in all therapeutic areas, managing the operational aspects of projects to meet contractual requirements. You will act as primary point of contact in the Netherlands to lead, manage and coordinate the conduct of clinical trials from study startup (COLA) to close out at a country level in accordance with ICHGCP and other applicable local regulations.

RESPONSIBILITIES OVERVIEW

· Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. (Accountable for study deliverables and drives key decisions within set country)

· Plan, manage, and maintain oversight of clinical study execution in accordance with the global program strategy, through leadership of the crossfunctional Local Study Team (LST)

· Support countrylevel operational planning and accountable for site selection within assigned country(ies)

· Contribute and develop to program,studyspecific materials – e.g., monitoring plan, study specific training documents.

· Accountable for sitelevel goal setting and studyspecific deliverables for clinical sites within their country(ies)

· Contribute to, deliver andor lead CRA, Investigator and Study Coordinator training

· Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning

· Contribute to the studylevel forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment longrange estimates) process

· Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:

· Monitor and review country and study trends, Review Monitoring Visit Reports

· Identify and facilitate resolution of crossfunctional studyspecific issues

· Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)

· Conducts onsite quality visits with CRAs wherewhen appropriate and supports the maintenance of investigator site relationships.

REQUIRED EDUCATION AND EXPERIENCE

· Bachelor’s degree in a healthcare or other scientific discipline

· Minimum 23 years’ experience of leading localregional or global teams

· Minimum 23 years’ clinical trial project management experience

· Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).

REQUIRED KNOWLEDGE

· Local knowledge expertise of regulatory environment, study start up process and associated timelines etc.

· Clinical trial processes and operations

· Extensive knowledge of ICHGCP regulations and guidelines

· Project and Program management including oversight of study deliverable, budgets and timelines

· Time, cost and quality metrics, Key performance indicators (KPIs)

· Fluent in Dutch and English is essential.

· Availability to travel occasionally across the country.

· Homebased role

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https:jobs.iqvia.com

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 https:jobs.iqvia.com