Sr. Site Contract Specialist/Principal Site Contract Specialist

Thermo Fisher Scientific•Morrisville, NC

4d•Onsite

About The Position

Join Us as Senior Site Contract Specialist- Make an Impact at the Forefront of Innovation! The Senior Site Contract Specialist manages the preparation, negotiation and finalization of the contracts process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity and risk analysis in the efficient delivery of Investigator Contracts. The role may involve mentoring junior staff. What You'll Do: Draft, review, negotiate and finalize agreements with study sites in accordance with local/accepted process. Negotiate within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with Company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes. Ensure compliance to established negotiation parameters, authority approval, contractual process and client expectations. Ensure compliance of budgetary guidance, templates and process. Identify and assess legal, financial and operational risks in accordance with company and client contractual considerations, and escalate to appropriate level of the organization per established processes. Provide recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels. Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation. Achieve target cycle times for site activations. Ensure guidelines and process are followed for efficient escalation of out of parameter issues, as applicable. Complete tracking and reporting as required. May provide training and mentoring to junior staff. Participate in country process improvement initiatives, representing Global Site Contract activities within country team meetings. Act as country subject matter expert in review of Investigator Contracts training materials. Liaise with Global Site Contracts to ensure full compliance with established global processes and corporate directives. Complete periodic quality reviews and peer feedback reports. May act as lead with amendment/novation client projects and oversight of confidentiality agreement negotiations.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Detailed understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
Effective communication skills (verbal & written) in English and local language
Detailed understanding and demonstrated ability to effectively negotiate investigator grant budgets within negotiation parameters
Demonstrated skill in strong attention to detail
Excellent analytical and decision based thinking skills
Solid knowledge and understanding of the pharmaceutical product development process and involvement of CROs
Able to work independently or in a team environment
Good organizational and time management skills
Working knowledge of PPD SOP & WPDs
Able to organize competing priorities logically and review outstanding contractual risk and issues
Able to effectively use automated systems and computerized applications
Ability to demonstrate a customer focused style of communication, problem solving and collaboration
Detailed understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
Detailed understanding and demonstrated ability to effectively negotiate investigator grant budgets within negotiation parameters
Demonstrated ability to independently train and mentor staff
Demonstrated ability to provide valuable feedback to Investigator Analysts
Strong problem solving skills that are demonstrated via solid risk analysis that results in resolution or escalation as appropriate
Demonstrated ability to effectively negotiate Investigator Contracts in the best interests and position of the company and client

Responsibilities

Draft, review, negotiate and finalize agreements with study sites in accordance with local/accepted process.
Negotiate within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with Company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.
Ensure compliance to established negotiation parameters, authority approval, contractual process and client expectations.
Ensure compliance of budgetary guidance, templates and process.
Identify and assess legal, financial and operational risks in accordance with company and client contractual considerations, and escalate to appropriate level of the organization per established processes.
Provide recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels.
Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
Achieve target cycle times for site activations.
Ensure guidelines and process are followed for efficient escalation of out of parameter issues, as applicable.
Complete tracking and reporting as required.
May provide training and mentoring to junior staff.
Participate in country process improvement initiatives, representing Global Site Contract activities within country team meetings.
Act as country subject matter expert in review of Investigator Contracts training materials.
Liaise with Global Site Contracts to ensure full compliance with established global processes and corporate directives.
Complete periodic quality reviews and peer feedback reports.
May act as lead with amendment/novation client projects and oversight of confidentiality agreement negotiations.