The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our clientâs project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
We currently offer the exciting opportunity to join the team as Local Study Operations Manager (m/w/d) in full-time and work home-based throughout Germany. In this role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local regulations. You will collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country
KEY RESPONSIBILITIES
- 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).
- 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.
- Communicate country status (including timelines and deliverables) to key stakeholders.
- Accountable for site-level goal setting 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.
- Engage with local cluster team and local functions from a study perspective (e.g., Local Medical, DOM).
- Provides country level input into the Country Operational Plan (COP) 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 (Country Level).
- 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
REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE
- Bachelorâs degree & 5 years of directly related experience
- Advanced knowledge of global clinical trial management including local knowledge / expertise of regulatory environment, study start up process and associated timelines.
- Advanced German level (min. C1)
- 2 yearsâ experience of leading local/regional teams
- Proven work experience in clinical trial project management
- Relevant Therapeutic knowledge (Obesity) is preferred
- Experience in oversight of external vendors
- Ability to work effectively in a team/matrix environment on multiple projects
- Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Risk management skills
- Strong organizational, self-management and planning skills
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.