Site Contracts Specialist – Japan – Remote

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

• Prepare country contract templates;

• Draft and send Site Agreements or any contracts associated to sites to begin negotiations;

• Negotiate contract(s) language and budget(s) with each assigned site to finalization / execution;

• Review study budgets and costs pertaining to contract negotiation;

• Perform quality check of Site Agreements or any documents associated before signature process starts;

• Liaise with Worldwide Legal Department, Data Privacy team, study teams, Sponsor, sites, investigators etc.

• 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 termination letter or any other type of documents related, and send to sites for signature, as applicable;

• Maintain tracking tool with live/real-time/regular updates for functional activities;

What you will bring to the role

• Proficient in negotiating contract terms with clinical sites and vendors.

• Ability to identify and address contract issues and disputes efficiently.

• Good understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).

• Solid analytical skills to review and interpret contract terms and financial data.

• Ability to identify risks and develop mitigation strategies.

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 and Japansese.

• Proficiency with MS Word, Excel and Outlook.

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.

Originally posted on Himalayas