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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Project Manager - EP
Job ID R0000041076 Berlin, Land Berlin, GermanyAn exciting opportunity for a Project Manager for our Early Phase Unit in Berlin. This role is a full-time and office-based position that will manage Phase I and II studies.
The Project Manager (PM) leads the Parexel and Sponsor teams by combining a depth of clinical research experience and project management skills with insight into sponsor pressures and an ability to develop the right solution for each sponsor.
Accountable for the successful delivery of projects/programs (on time, on budget, to the highest quality) compliant with ICH, GCP, and other applicable documents and regulations. Ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy.
Key Accountabilities:
- Initiate, plan, manage and close out of Phase I and II projects with all departments of the EPCU Berlin including external vendors and external units as required
- Owns the sponsor relationship and is responsible for sponsor communications.
- Provides a central point of study contact on behalf of the functional teams and vendors.
- Continuous reporting and update of project progress including communication internally and with sponsor and external vendors
- Lead team meetings on a regular basis with project team to ensure project objectives are met.
- Budget control for Phase I and II studies including: Service inquiries with external vendors, Budget and contract negotiation with sponsors and external vendors, Forecasting, tracking and invoicing
- Understands and ensures compliance with SOP's, contract terms and system requirements.
- Responsible for the setup of project specific training in Parexel system and oversight of training.
Skills & Knowledge
- Proven Project Management experience in the field of clinical research
- Experience as a functional team leader in clinical/data management/logistics function or proven experience in coordinating clinical trials
- Presentation, speaking skills in English and German
- Organizational talent and Ability to work under pressure and multitask
- In depth knowledge of guidelines, ICH-GCP and AMG.
- Solid computer and internet skills including knowledge of MS Office (e.g. Excel, Word, PowerPoint and Project).
Education:
- Bachelor's degree in a science related filed or a wealth of related work experience as a clinical research project manager.
- Scientific / Medical / Pharmacology background desirable.
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