Senior Specialist

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 Sr. Specialist, Site Contracts does at Worldwide Senior Specialist, Site Contracts is responsible for developing, reviewing, and assisting with the negotiation of Site Agreements with Institutions and Investigators and providing oversight and expertise to all site contract activities during all stages of a Clinical Trial. This includes the development of investigator grants, Clinical Trial Agreement templates and applicable plans, negotiation of Clinical Trial Agreements and ancillary agreements, and mitigation of site contracting risks. What you will do Prepare country contract templates Draft and send Site Agreements or any contracts associated with sites to begin negotiations Provide site contract execution planned timelines and site negotiation status Send items for translation, if applicable, and receive and translate items Review study budgets and costs pertaining to contract negotiation Negotiate contract language and budgets with each assigned site through finalization and execution Escalate sponsor site requests outside of preapproved parameters Escalate risks and non-responsive sites to the Site Contracts Lead or internal team, as applicable If required to provide equipment to sites, ensure appropriate information or appendices are added to Site Agreements or associated documents Create donation agreements, as applicable Review Site Agreements or any associated contracts for completeness and accuracy Finalize contracts and budgets with sites Perform quality checks of Site Agreements or associated contracts before the signature process begins If requested, provide draft or signed contracts and budgets to the regulatory team for submission purposes, where needed Liaise with Worldwide Clinical Trials Legal Department, Data Privacy team, study teams, sponsors, sites, investigators, and other stakeholders Facilitate contract signatures by Worldwide Clinical Trials, when applicable Send fully executed Site Agreements or associated documents to sites, electronic Trial Master File (eTMF), payment team, sponsors, and post to internal SharePoint, as applicable Negotiate Site Agreement amendment language and budgets with sites Create termination letters and send them to sites for signature, as applicable Maintain tracking tools with live, real-time updates for functional activities Prioritize effectively and respond to urgent requests within the internal team or sponsor Review Trial Master File (TMF) structure, oversee Investigator Grants Budgets, and ensure quality checks for site agreements Act as a lead and subject matter expert on site agreements and related processes, prepare and update contract templates, coordinate master budgets and contract and budget plans, send these to the sponsor, and manage site agreements Maintain tracking tools, communicate site contracting strategies, timelines, and tracking requirements, and escalate issues as necessary Develop mitigation plans, resolve contract negotiation issues, and contribute to process improvement initiatives Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. What you bring to the role Advanced Contract Negotiation Proficient in negotiating complex contract terms with clinical sites and vendors Skilled in resolving contract issues and disputes efficiently Regulatory Compliance Thorough understanding of international and local regulatory requirements for clinical trials (e.g., U.S. Food and Drug Administration [FDA], European Medicines Agency [EMA], International Council for Harmonisation - Good Clinical Practice [ICH-GCP]) Ensures all contracts comply with the latest regulations and guidelines Communication Excellent verbal and written communication skills for effective interaction with internal stakeholders and clinical sites Ability to clearly explain complex contract terms and processes Strong problem-solving skills to address and resolve contract-related issues Ability to think critically and strategically to overcome challenges Collaboration and Teamwork Ability to work effectively with cross-functional teams, including legal, finance, and clinical operations Skilled in fostering a collaborative work environment Technical Proficiency Proficiency in contract management software and tools 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 perform under pressure Strong project management skills to oversee multiple site contracts simultaneously Ability to prioritize tasks, manage timelines, and ensure contract deliverables are met Advanced analytical skills to review and interpret contract terms and financial data Ability to identify risks and develop mitigation strategies Your experience 3 to 5 years of experience as a Contract Specialist in the