Specialist, Site Contracts - UK- Remote

Worldwide Clinical Trials; United Kingdom; Remote; GBP 30,000 - 45,000; Full time

Job summary

A leading global CRO is seeking a Contract Negotiator to join their Site Contract department, responsible for drafting and negotiating clinical trial contracts. The ideal candidate will possess strong negotiation skills, a background in Clinical Research, and the ability to manage multiple contracts efficiently. Join a company that values diversity, creativity, and integrity while making a significant impact on patient lives.

Benefits

Inclusive work environment

Career development opportunities

Collaborative team culture

Qualifications

• 1 to 3 years of experience in Clinical Research, Pharmaceutical or CRO industry.
• Excellent verbal and written English language skills.
• Knowledge of ICH and GCP Guidelines.

Responsibilities

• Prepare and negotiate site contracts with clinical sites.
• Review and draft contracts ensuring compliance with regulations.
• Maintain contract tracking tools with live updates.

Skills

Contract Negotiation

Regulatory Compliance

Problem-Solving

Time Management

Budgeting Principles

Education

Bachelor's Degree in Business Administration, Finance, Science or related field

Tools

Contract Management Software

MS Word

MS Excel

MS 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 d rafting 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 will you do

• Local negotiation: Prepare country contract templates.
• Draft and send Site Agreements or any contracts associated to sites to begin negotiations;
• Provide site contract execution planned timelines and site negotiation status.
• Send items for translation, if applicable. Receive and translate items;
• Reviewing study budgets and costs pertaining to contract negotiation;
• Negotiate contract(s) language and budget(s) with each assigned site to finalization/execution;
• Escalate to Site Contracts Lead site requests outside of pre-approved parameters, to be forwarded to the Sponsor.
• Escalate risks and non-responsive sites to Site Contracts Lead or internal team, as applicable;
• If required to provide equipment to the sites, ensure appropriate information or an appendix is added in Site Agreements or any associated documents.
• Create a donation agreement, as applicable.
• Review Site Agreements or any contracts associated for completeness and accuracy;
• Finalize contract and budget with sites.
• Perform quality checks of Site Agreements or any documents associated before the signature process starts;
• If requested, provide draft/signed contract/budget to the regulatory team for submission purposes, where needed.
• Liaising with Worldwide Legal Department, Data Privacy team, study teams, Sponsor, sites, investigators etc.
• Facilitate contract signatures by Worldwide, when applicable;
• Send Fully Executed Site Agreements or any document associated to: site, eTMF, payment team, Sponsor, post to internal SharePoint, as applicable;
• Negotiate Site Agreements, Amendment language and budget with sites;
• Create a termination letter or any other type of document related, and send to sites for signature, as applicable;
• Maintain a tracking tool with live/real-time/regular updates for functional activities;
• Prioritizes effectively and responds to urgent requests within an internal team or the Sponsor.

What you will bring to the role

• Contract Negotiation/Proficient in negotiating contract terms with clinical sites and vendors.
• Ability to identify and address contract issues and disputes efficiently.
• Regulatory Compliance/Good understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).
• Ensure all contracts comply with the latest regulations and guidelines.
• Technical Proficiency/Proficiency in contract management software and tools.
• Strong problem-solving skills to address and resolve contract-related issues.
• High level of accuracy in reviewing and drafting contracts.
• Ability to identify and correct discrepancies or potential issues in contract documentation.
• Understanding of budgeting and financial principles related to clinical trial contracts.
• Ability to negotiate cost-effective terms and manage financial aspects of contracts.
• Basic understanding of legal terminology and principles related to contracts.
• Ability to work closely with legal counsel to ensure all contracts meet legal and regulatory requirements.
• Strong time management skills to meet deadlines and manage the contract lifecycle efficiently.
• Ability to handle high volumes of work and work under pressure.

Your experience

• Bachelor's Degree or equivalent in business administration, finance, science or related field.
• 1 to 3 years of experience in Clinical Research, Pharmaceutical, or CRO industry working with investigator/site contracts or related legal field.
• Excellent verbal and written English language skills.
• 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.

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’reon a mission to hire thevery bestand 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.