Site Contracts Lead - Europe - Remote

What You Will Do

• Be the main point of contact for Project Team and Sponsor, for all Study site contracting activities, during the life of contracting on the Study.
• Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level.
• Agrees and negotiates Clinical Trial Agreements templates, fall back language and sites budget negotiation parameters with Global Project Lead and Sponsor.
• Supports, supervises, and mentors allocated Site Contracts Specialists, ensuring effective planning, effective communication, on time issues escalation, problem solving and execution.
• Negotiation and finalization or assistance in negotiation and finalization of Site Contracts with Worldwide Legal Department, project team, Sponsors, investigators and/or clinical sites, as well as amending and terminating such contracts.
• Accountable for maintaining the housing of all draft, finalized, and executed Study contracting documents within each Study Sharepoint.
• Creates and delivers on-going departmental trainings on various topics provided by contract management team.

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).
• Excellent verbal and written communication skills to interact with internal stakeholders, clinical sites, Sponsors, and regulatory authorities, if required.
• Ability to explain complex contract terms clearly and concisely.
• Proven leadership skills to guide and mentor a team of contract specialists.
• Ability to collaborate effectively with cross-functional teams, including but not limited to legal, finance, data protection and clinical operations.

Your Experience

• Up to 2 years of experience as a Principal Site Contracts Specialist and 2 – 3 years’ experience leading projects OR
• Minimum 6 years Site Contract experience in Clinical Research Pharmaceutical or CRO industry and 2 – 3 years’ experience leading projects.
• Bachelor's Degree or equivalent in business administration, finance, science or related field.
• Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements.
• High degree of organizational, analytical, and team management skills.
• Adept knowledge of biopharmaceutical/CRO industry and applicable local regulatory requirements.

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

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide 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.