Senior Specialist
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Job Description
Senior Site Contracts Specialist negotiating clinical trial agreements, budgets, and amendments for Worldwide Clinical Trials, a global clinical research organization. Managing site contracting risks, compliance, and execution.
Responsibilities:
- Develop, review, and assist with negotiation of Site Agreements with institutions and investigators
- Provide oversight and expertise for site contract activities throughout clinical trials
- Develop investigator grants, Clinical Trial Agreement templates, and applicable plans
- Prepare country contract templates
- Draft and send Site Agreements and site-related contracts for negotiation
- Provide execution timelines and site negotiation status
- Coordinate translation of contract materials when applicable
- Review study budgets and costs related to contract negotiation
- Negotiate contract language and budgets through finalization and execution
- Escalate requests outside preapproved parameters, risks, and non-responsive sites
- Add equipment information or appendices to Site Agreements when required
- Create donation agreements and termination letters as applicable
- Review contracts for completeness and accuracy
- Finalize contracts and budgets with sites
- Perform quality checks before signature processes
- Provide contracts and budgets to regulatory teams for submissions when requested
- Liaise with legal, data privacy, study teams, sponsors, sites, investigators, and other stakeholders
- Facilitate contract signatures
- Distribute executed agreements to sites, eTMF, payment teams, sponsors, and internal SharePoint
- Maintain real-time tracking tools
- Review TMF structure and oversee Investigator Grants Budgets
- Act as lead and subject matter expert on site agreements and related processes
- Coordinate master budgets, contract plans, and budget plans
- Communicate contracting strategies, timelines, and tracking requirements
- Develop mitigation plans, resolve negotiation issues, and contribute to process improvement initiatives
- Perform other duties as assigned
Requirements:
- 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
- Knowledge of local country legislation in the sphere of clinical trials and local regulatory requirements
- Advanced contract negotiation skills
- Proficiency negotiating complex contract terms with clinical sites and vendors
- Understanding of international and local clinical trial regulatory requirements, including FDA, EMA, and ICH-GCP
- Proficiency in contract management software and tools
- Understanding of budgeting and financial principles related to clinical trial contracts
- Basic understanding of legal terminology and contract principles
- Strong project management, analytical, time management, and problem-solving skills
- Ability to manage multiple site contracts, timelines, risks, and deliverables
- Ability to work effectively with cross-functional teams
- Ability to handle high volumes of work and perform under pressure
Benefits:
- Competitive benefits package depending on location
- Inclusive and equitable workplace
- Transparent compensation
- Pay equity and compensation transparency
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