Senior Specialist, Site Contracts

Worldwide Clinical Trials•Carolina, NC

2d•$71,500 - $142,500

About The Position

The Senior Specialist, Site Contracts is responsible for developing, reviewing, and assisting with the negotiation of Site Agreements with Institutions and Investigators. This role provides oversight and expertise to all site contract activities throughout all stages of a Clinical Trial. Key responsibilities include 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.

Requirements

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.
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.

Responsibilities

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.