Site Contracts Lead

Site Contracts Lead - Remote, US

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Summary of Job Specification

The Site Contracts Lead is responsible for assisting and supporting the facilitation and implementation of the strategy of the Site Contracts function as finalized by Director, Site Contracts, with focus on increasing customer satisfaction, creating efficiencies and continuous improvement of Site Contracts processes. 

This role will assist in supporting the maintenance of quality and management of the logistics and life cycle of multiple site contracts in order to maximize KCR’s profit on each site contract.

The Site Contracts Lead establishes the site contracting strategy, oversees, manages, supports and participates in the realization of all aspects related to study site contracting according to KCR’s contracted scope, Standard Operating Procedures (SOP), Good Clinical Practices (GCPs), International Conference on Harmonization (ICH) guidelines and local laws and regulations.

Detailed Job Duties and Responsibilities

• Assisting and supporting the facilitation and the implementation, of the review and maintenance of KCR site contracting processes, templates, negotiation parameters, systems and tools required for effective process execution across the KCR portfolio by the Site Contracts team. Reports progress to Director, Site Contracts.
• Acts as a subject matter expert, in the administration of site contracts, negotiation techniques, resolutions and strategies
• Assists and supports in the development, implementation, use and maintenance of country intelligence data for country and sites contracting process (library) by the Site Contracts team;
• Oversees and manages study site contracting (site contracts & amendments) process at all stages of a project from award to site closure. Serves as communication liaison between site contracts staff and internal and external customers, vendors, and company advisors, as required.
• Develops and implements study level negotiation parameters, strategies and agendas with sponsors prior to site contract negotiations
• Creates study specific templates and documents to negotiate and finalize site contracts, in line with sponsor requirements, including, but not limited to Confidentiality Agreements, Amendments, Clinical Trial Agreements and Service Agreements with medical centers
• Contributes to the development of study site investigator budget(s), ensuring that each study site investigator budget has the right structure/content and is approved by Sponsor before its distribution to Site Contracts Specialists, country level team members and sites
• Directly negotiates and arranges execution of study sites contracts, working collaboratively with operational teams, if required, as well a filing requirements
• Raises Study Work Order out of scope needs to Director, Site Contracts and assigned Project Manager, providing rationale for request
• Participates in internal and external teleconferences/meetings and study level Kick Off Meetings
• Participates in sponsor audits, and Regulatory Authority inspections, if necessary

Education / Qualifications / Skills Requirements

• Bachelor’s Degree and 3+ years of relevant work experience, including at least two years as an international Site Contracts Lead
• Strong understanding of commercial contracting principles and legal terms and conditions
• Ability to work in a dynamic fast-paced, high volume environment and meet deadlines
• Strong organizational and time management skills to balance working on multiple projects in parallel
• Strong interpersonal, collaboration, influencing and negotiation skills as well as excellent verbal and written communication skills
• Ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization

Travel

• Available for travel occasionally, up to 10%, including overnight stays as necessary, consistent with project needs and office location. Ability to travel locally and internationally.

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What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused o