FSP Contract Specialist

Work Schedule Environmental Conditions

Job Description

Join Us as a Site Contract Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to prepare and negotiate contracts, as well as finalize the contract process. As a Site Contract Specialist, you'll liaise and establish effective relationships with sites and internal functional teams. You will ensure quality, objectivity, and risk analysis in the efficient delivery of contracts. What You’ll Do:

• 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 Investigator 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.
• Achieve target cycle times for site activations.
• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.

Education and 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 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 for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:

• 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 that related to service agreements
• Effective communication skills (verbal & written) in English and local language
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
• Demonstrated ability in 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 & 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

Working Conditions and Environment:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.