Principal Site Contract Specialist (Clinical Trial)

Job Description

Essential Function:

• Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.• Negotiates 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. • Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations.• Ensures compliance of budgetary guidance, templates and process. • Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes.• Provides recommendations and alternative resolutions to contracts negotiations through established escalation channels.• Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.• Achieves target cycle times for site activations.• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.• Provides training and mentoring to junior staff.• Participates in country process improvement initiatives, representing Global Site Contract activities within country team meetings. • Acts as country subject matter expert in review of contracts training materials.• Liaises with Global Site Contracts to ensure full compliance with established global processes and corporate directives.• Completes periodic quality reviews and peer feedback reports. • Serves as lead with amendment/novation client projects and oversight of confidentiality agreement negotiations.• Owns and manages training plans and content for local teams and Contract Specialists for a country or series of countries.• Drafts and provides input to improvement/revisions and rationale to Site Contracts management team on Investigator Contracts documents.• May mentor junior staff.

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ 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. 

Knowledge, Skills and Abilities: • Effective communication skills (verbal & written) in English and local language • Mastery level of 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• Mastery 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 and insight to country or regional budgetary trends• Excellent problem solving, risk assessment and impact analysis abilities• Flexible and able to multi-task and prioritize competing demands/resolve complex issues• Mastery ability to effectively and efficiently escalate out of parameter issues and offer resolution suggestions• Demonstrated ability to effectively negotiate contracts in the best interests and position of the company and the client• May act as first point of the escalation pathway for specialists• Liaison between Country Team and Global Site Contracts Tea