Site Contracts Lead - Europe - Remote
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AI Summary
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Site Contract department does at Worldwide
Site Contracting is an essential function within any CRO, and our seasoned team spans decades of experience within the industry and possesses robust legal experience as well. The department is responsible for reviewing, analyzing, and drafting clinical research site contracts, investigator contracts, and other project-related contracts. Our global team is familiar with the specific laws for the countries and sites we occupy. We negotiate and finalize clinical trial contracts and services contracts with the Worldwide Legal Department, study teams, Sponsors, investigators, and/or clinical sites.
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.
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