We currently offer the exciting opportunity to join the team as Local Trial Manager (m/w/d) in our sponsor dedicated cFSP team in full-time and work in home-office throughout Germany.

In this role you will act as primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials and collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country.

Your responsibilities will include:

• Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery.
• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)
• Supports country-level operational planning and accountable for site selection within assigned country.
• Contribute and develop to program / study-specific materials – e.g., monitoring plan, study specific training documents.
• Support and contribute to Clinical Study Teams as applicable, agenda driven, present at meetings.
• Communicate country status (including timelines and deliverables) to key stakeholders with oversight as required and ensures updates to relevant systems.
• Accountable for site-level goalsetting and study-specific deliverables for clinical sites within their country.
• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training.
• Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
• Engage with local cluster team and local functions from a study perspective.
• Provides country level input into the Country Operational Plan and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
• Accountable for approval of Baseline and Revised Enrolment Plans.
• Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.
• Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:
• - Translate global start up requirements into local country targets.
• - Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
• - Monitor and act upon data flow metrics-review, trend identification and analysis, with targeted follow up where appropriate.
• - Review Monitoring Visit Reports. Escalate CRA performance issues to applicable line manager.
• - Identify and facilitate resolution of cross-functional study-specific issues.
• - Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships.
• - Execute regulatory agency inspection readiness activities (e.g., TMF review, story board generation). Support internal audit and inspection activities.
• - Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management.
• - Collaborating with local teams to ensure country level study delivery is aligned with global expectations.
• - Coordination of the site contracting, budgeting, insurance and payment process by overseeing local support roles (e.g., CTA, SCBA, Legal).
• - Identifying risk, implementing risk mitigation strategies, and resolving issues at a country/site level, as well as informing the CST/TMT, LST and local teams of risks associated with delivery in a proactive, timely and solution orientated manner. Contribute to study-level risk assessments.

Qualifications:

• Bachelor’s or higher-level degree in life science.
• Minimum of 5-7 years’ experience within the clinical research environment in a pharmaceutical company or CRO plus a minimum of 3 years of clinical trial management experience.
• Advanced knowledge of global clinical trial management.
• Strong working knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Fluent languages skills in German on at least C1 level and good command of English.
• Strong IT skills in appropriate software and company systems.
• Excellent decision-making and string financial management skills.
• Flexibility and ability to manage study teams in a virtual environment.
• Willingness to travel occasionally for business meetings.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA.

Please apply with your English CV, motivation letter and your certificates and reference letters.

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