What the Specialist, Site Contract does at Worldwide

The Specialist, Site Contracts is responsible for the development, preparation, negotiation, and finalization, or assistance in preparation, negotiation, and finalization, of Site Agreements, amendments, or any other document associated between sponsors and clinical research sites

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 to finalization/execution

• Escalate site requests outside of preapproved parameters to the Site Contracts Lead for forwarding to the Sponsor

• Escalate risks and non-responsive sites to the Site Contracts Lead or internal team, as applicable

• Ensure appropriate information or appendices are added to Site Agreements or related documents when equipment is provided to sites

• Create donation agreements, as applicable

• Review Site Agreements or associated contracts for completeness and accuracy

• Finalize contracts and budgets with sites

• Perform quality checks of Site Agreements or associated documents before the signature process begins

• Provide draft or signed contracts and budgets to the regulatory team for submission purposes when requested

• Liaise with Worldwide Clinical Trials Legal Department, Data Privacy team, study teams, Sponsors, sites, investigators, and others as needed

• Facilitate contract signatures by Worldwide Clinical Trials, when applicable

• Distribute fully executed Site Agreements or associated documents to sites, eTMF, payment team, Sponsor, and post to internal SharePoint, as applicable

• Negotiate Site Agreement amendment language and budgets with sites

• Create termination letters or other related documents and send to sites for signature, as applicable

• Maintain tracking tools with live, real-time, or regular updates for functional activities

• Prioritize effectively and respond to urgent requests within the internal team or from Sponsors

• 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

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., U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonization - Good Clinical Practice (ICH-GCP))

• Ensure 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 contract terms and processes

• Strong analytical skills to review and interpret contract terms and financial data

• Ability to identify risks and develop mitigation strategies

Collaboration and Teamwork:

• Ability to work effectively with cross-functional teams, including legal, finance, and clinical operations

• Strong project management skills to handle multiple site contracts simultaneously

• Ability to prioritize tasks, manage timelines, and ensure contract deliverables are met

Technical Proficiency:

• Proficiency in contract management software and tools

• Strong problem-solving skills to address and resolve contract-related issues

• Ability to think critically and strategically to overcome challenges

• 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 a related field

• 1 to 3 years of experience in the Contract Research Organization, pharmaceutical, or clinical research industry, working with investigator/site contracts or a related legal field

• Excellent verbal and written English language skills

• Proficiency with Microsoft Word, Excel, and Outlook

• Knowledge and understanding of International Council for Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, as well as local country legislation and regulatory requirements related to clinical trials

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.