Contract Specialist - FSP

Overview

Site Contract Specialist supporting clinical trial site contracts, preparing and negotiating agreements and finalizing the contract process at the forefront of innovation.

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 and 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 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, and that contract negotiation process for sites and study are aligned to the critical path for site activation.
• Achieve target cycle times for site activations.
• Ensure guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.

What you'll need

• 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 2-5 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient.
• Good 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.
• Demonstrated ability to apply basic principles of investigator grant negotiation.
• General understanding of business and financial principles related to service agreements.
• Effective communication skills (verbal and written) in English and local language.
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters.
• Demonstrated attention to detail.
• Excellent analytical and decision-based thinking skills.
• 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 and 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.

Details

• Work schedule: standard, Monday to Friday.
• Office job; environmental conditions: ability to work in an upright and/or stationary position for 6-8 hours per day; frequent mobility; occasional crouching and stooping; light to moderate lifting and carrying up to 15-20 lbs (including luggage and laptop).
• Repetitive hand movement of both hands, with ability to make fast, simple, repeated movements of fingers, hands and wrists.
• Ability to use a variety of in-house and off-the-shelf computer software.
• Frequently interacts with diverse groups to obtain or relate information; ability to perform under stress and multi-task with variable, changing demands.
• Regular and consistent attendance required.