Position Summary:Support in the creation and maintenance of Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines. Support in the development of training related to Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines as required. Lead/support on the review and negotiation of customized and complex templates. Expedite contract negotiation and execution by acting as resource for first line negotiators to streamline requests to law department and avoid duplication of efforts among negotiators. Act as a point of contact with legal department to resolve complex legal issues while ensuring compliance with company process and strategy and subsequently disseminating information to negotiators.Principal Responsibilities:• Support creation and maintenance of contract templates in accordance with changes in laws, regulations, or corporate policies• Support creation and maintenance of fallback language and negotiation guidelines related to contract templates• Support training on contract templates and fallback language and provide training to first line negotiators and others as required• Provide specialized support and guidance on the negotiation of CTAs and CDAs to first line negotiators• Work with the legal department to create risk assessments to support the decision-making process• Access risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provide guidance to 1st line negotiators, stakeholders and others as required• Lead negotiations on Master Agreements and custom templates or those requiring extensive modifications and identify potential risks to the business• Lead contract negotiations on terms and conditions of high-risk and complex agreements and other relevant legal documents as they relate to clinical trials and company/departmental policies

• Responsible for the timely and quality delivery of the site contracts at a project level, ensuring consistent negotiation and closely monitoring the process throughout.• Creation of guidelines for contract negotiation and lead the Contracts Associates (CA) assigned to the project.• To provide CA’s with adequate training on contracts and negotiation instructions with up-to-date information and templates.• To work closely with the Legal Counsels, the Project Managers and Country Experts, and serve as the primary escalation point for contract negotiation issues.• Primary U.S. contract specialist contact for contract negotiations in the therapeutic area of Infectious Disease.• Primary U.S. contract specialist contact for negotiations of VA CRADA’s.• Sole U.S. contract specialist contact for contract negotiations for Biomedical Advanced Research and Development Authority (BARDA) studies.• Creation and development of fallback documents for use by contract specialists.

• Lead management role and subject matter expert in IQVIA Precision Enrollment Project contract negotiations.• Lead contract negotiator for MCTA/CTA/work orders in direct contact with the legal department on the IQVIA Precision Enrollment Project. • Manage Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions to facilitate execution of clinical trial agreements.• Review, prepare and negotiate site contracts and budgets with sites.• Ensure accurate completion and maintenance of internal systems (such as CTMS/ELVIS/Workflow), databases and tracking tools with project specific information.• Review and provide feedback to management on site performance metrics.• Review, establish and agree on project planning and project timelines. • Manage and perform tasks at country level associated with Regulatory, Start-Up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. • Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverable's and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.• Assist with training of on-boarding negotiators.

• Draft, review, negotiate and finalize agreements with study sites in accordance with local and global accepted standards.• Ensure compliance of negotiation parameters, authority approval, contractual and budgetary process and client expectations.• Identify and assess legal, financial and operational risks in accordance with PPD and client contractual considerations.• Serve as contact with investigative sites for contractual issues and negotiations throughout the lifecycle of a study.• Ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.• Assume responsibility for any ongoing contract or budget amendments.• Train on-boarding Contract Specialists.*Given Level 1 site recognition for assisting in achieving first qualified to first patient screened in 22 days. *Recognized for pragmatic approach, patient but clear and firm way of dealing with key stake holders.

• Contract and Employment Litigation• Drafted and negotiated employment contracts• Real Estate, Wills, and Trusts• Speeding tickets, and misdemeanors• Controlled and maintained billing • Supervised employees • Facilitated all promotion techniques and advertisement

Juris Doctorate