Senior Specialist

Worldwide Clinical Trials Holdings, Inc.; North Carolina; Hybrid; USD 72,000 - 143,000; Full time

Job summary

Worldwide Clinical Trials in the United States is seeking a Senior Specialist, Site Contracts to develop, review and negotiate site agreements with institutions and investigators, guiding contracting through all stages of a clinical trial.

You will draft budgets and templates, coordinate with the legal, data privacy, study teams and sponsors, ensure compliant terms, manage timelines, and drive quality checks and timely site contract execution across global sites.

Qualifications

• 3 to 5 years of Contract Specialist experience in clinical research, pharma, or CRO.
• Excellent verbal and written English language skills.

Responsibilities

• Develop, review and negotiate site contracts and budgets.
• Coordinate with legal, data privacy, study teams and sponsors.
• Maintain tracking tools and ensure timely execution of Site Agreements.

Skills

Advanced contract negotiation

Regulatory compliance

Communication

Problem solving

Cross-functional collaboration

Budgeting & financials

Contract management software

Attention to detail

Education

Bachelor's degree or equivalent in business, finance, science, or related field

Tools

Microsoft Word

Excel

Job description

Join us!

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.

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.

• 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 elevate issues as necessary
• Develop mitigation plans, resolve contract negotiation issues, and contribute to process improvement initiatives
• Perform other duties as assigned

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 clinical research, pharmaceutical, or Contract Research Organization industry
• Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related field
• Excellent verbal and written English language skills
• Proficiency with Microsoft Word, Excel, and Outlook
• Knowledge and understanding of International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $71,500.00 - $142,500.00 The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. We love knowing that someone is going to have a better life because of the work we do.

Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn. This is who we are.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.