FSP Associate Contract Specialist/Contract Specialist

Overview

The organization is seeking a Site Contract Specialist to help prepare, negotiate, and finalize contracts for clinical study sites and principal investigators. This role includes drafting contract documents, managing contract processes, coordinating reviews and escalations, and ensuring timely documentation in the electronic trial master file.

• Work Schedule: Standard (Mon–Fri)
• Environmental Conditions: Office
• Employment Type: Fully remote (candidates located in the United States)

This hiring may include Associate Contract Specialist and Contract Specialist candidates. Job leveling will be determined based on qualifications and experience.

Responsibilities

• Draft, execute, and process various contracts, reports, and related documents with clinical study sites and principal investigators.
• Develop and maintain professional relationships with assigned sites.
• Negotiate within approved parameters both investigator grant budgets and contractual terms and conditions, following client negotiation parameters, established client processes, and escalation routes.
• Coordinate stakeholder review of changes outside negotiation parameters and submit recommendations to resolve negotiations.
• Monitor and report contractual progress to the Site Contract Manager.
• Partner to reduce and/or eliminate company regulatory, legal, and financial exposure.
• Initiate and coordinate follow-up with stakeholders on outstanding agreement issues in accordance with agreed process documents.
• Ensure finalized contractual documents are uploaded to eTMF within required timelines.
• Assist TMF specialist with eTMF QC and issue resolution in accordance with agreed process.
• Track common negotiation points for updates to negotiation parameters in accordance with agreed process documents.

Requirements

• Education: Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.

Associate Contract Specialist

• Comparable experience providing the knowledge, skills, and abilities to perform the job (comparable to 2 years).

Contract Specialist

• Comparable experience providing 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 may be considered sufficient to meet the requirements.

Knowledge, Skills, and Abilities

• Good understanding of contract law principles, including laws that influence contract language (e.g., 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.
• Ability, with appropriate oversight, to draft and negotiate contract provisions and budgetary issues within parameters.
• Demonstrated attention to detail.
• Excellent analytical and decision-based thinking.
• Understanding of the pharmaceutical product development process and involvement of CROs.
• Ability to work independently or in a team environment.
• Strong organizational and time management skills.
• Working knowledge of PPD SOP & WPDs.
• Ability to organize competing priorities logically and review outstanding contractual risk and issues.
• Ability to effectively use automated systems and computerized applications.
• Ability to demonstrate a customer-focused style of communication, problem-solving, and collaboration.

Compensation & Benefits

Not specified.

Location

• Fully remote position for candidates located in the United States.

Working Conditions and Environment

• Ability to work in an upright and/or stationary position for 6–8 hours per day.
• Repetitive hand movements of both hands with the ability to make fast, simple, repeated movements of fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching and stooping, with frequent bending and twisting of the upper body and neck.
• Light to moderate lifting and carrying (or otherwise moving) objects including luggage and a 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; 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 regarding task occurrence; ability to perform under stress and multi-task.
• Regular and consistent attendance.