Specialist, Site Contracts - 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 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 ma...