Principal Specialist, Site Contracts - Germany - Remote

Worldwide Clinical Trials; Berlin; Remote; EUR 80,000 - 110,000; Full time

Job summary

Worldwide Clinical Trials in Berlin is seeking a Senior Site Contracts Specialist to lead site contract negotiations for global clinical studies. You will manage budgets, draft and finalize agreements, and collaborate with legal, finance and study teams.

The role requires 3-4 years of senior site contracts experience in CRO/Pharma, a Bachelor’s degree, and strong knowledge of ICH-GCP and regulatory requirements. German work authorization preferred; on-site presence is expected.

Qualifications

• 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.

Responsibilities

• 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

Skills

Contract negotiation

Clinical trial contracts

Regulatory knowledge ICH-GCP

Leadership

Cross-functional collaboration

Education

Bachelor’s Degree or equivalent

Tools

MS Word

MS Excel

Outlook

Job description

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

• 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 liason for contract related communications
• Resolve negotiation issues and escalating risks, drive process for improvements, contribute to SOP develoment 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.

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