Study Start Up and Contracts Specialist (FSP) in Home Office bei Parexel

ABOUT THIS ROLE

Parexel FSP is currently hiring for a Study Start-up & Contracts Specialist

Home-based in Germany. Permanent, full-time.

Single sponsor dedicated to a global biotechnology company that has been developing novel cancer therapeutics for over 25 years. Their research efforts are currently focused on advancing innovative therapies for solid tumors, Hodgkin’s lymphoma, and blood-related cancers. Dedicated to revolutionizing cancer care by developing transformative therapies that make a meaningful difference in people’s lives. They work with urgency to improve and extend the lives of people living with cancer.

Position Summary

The Study Start-Up and contracts Specialist is responsible for supporting Site Study Start-Up (SSU) activities, including collection and review of essential documents, preparing Informed Consent Forms (ICFs), obtaining ethics committee approval for assigned clinical sites, and serving as a conduit between Clinical Operations and the Legal Group for clinical contract requests.

Skills and Experience required to be considered for this position:

• Minimum of four (4) years of relevant clinical trial experience working in a Pharma, Biotech, or CRO environment.

• Minimum of four (4) years of a clinical trial or equivalent Start-Up unit experience and/or experience negotiating contract language, payment terms, and budgets.

• Thorough knowledge of clinical Start-Up process and requirements.

• Knowledge of CFR and ICH/GCP requirements is required.

• Oncology clinical research experience is preferred.

• Intermediate proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint

• Proficiency in English written and verbal communication.

• Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training

Great pay and benefits & and a supportive line manager.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel FSP

For more information contact Trish.Arnold@parexel.com

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