[Hiring] Principal Specialist, Site Contracts @Worldwide Clinical Trials

Role Description

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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• Equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.