About this role

Principal Specialist, Site Contracts - Germany - Remote

Remote

Berlin, Germany

Vienna, Austria

Full time

Posted Today

JR102875

What you will do

Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level
Preparation, negotiation and finalization of site contracts and budgets
Manage the Investigator Budget and act as a key liaison for contract related communications
Resolve negotiation issues and escalating risks, drive process for improvements, contribute to SOP development and keep templates updated
Liaising and collaborating with Worldwide stakeholders as well as external stakeholders (such as sites, investigators etc.)
Review and finalize Clinical Trial Agreements and/or any document associated including site budget, for completeness and accuracy

What you will bring to the role

Mastery in negotiating complex contract terms with clinical sites and vendors
In-depth understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP)
Ability to explain complex contract terms clearly and concisely
Leadership skills to guide and support junior contract specialists
Ability to collaborate effectively with cross-functional teams, including but not limited to legal, finance, data protection and clinical operations.

Your experience

3- 4 years of experience as a Senior Site Contracts Specialist or minimum 5 years Site Contract experience in Clinical Research Pharmaceutical or CRO industry
Bachelor's Degree or equivalent in business administration, finance, law, science or related field
Proficiency with MS Word, Excel and Outlook
Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements.

We love knowing that someone is going to have a better life because of the work we do.

Principal Specialist, Site Contracts - Germany - Remote