Senior Site Contract Specialist

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.
• 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 and escalate to appropriate level per established processes.
• Provide recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels.
• Coordinate with internal functional departments to ensure site startup activities are aligned with contractual activities and timelines.
• Achieve target cycle times for site activations.
• Complete tracking and reporting as required.
• May provide training and mentoring to junior staff.
• Participate in country process improvement initiatives.
• 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.

Education & Experience 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).

Knowledge, Skills, Abilities

• 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
• 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