FSP Associate Contract Specialist/Contract Specialist

About the job

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

*We are currently hiring for Associate Contract Specialist and Contract Specialist candidates. Job leveling to be determined based on qualifications and experience. *

This is a fully remote position for candidates located in the United States.

Essential Functions:

• Drafts, executes and processes various company contracts, reports and related documents with clinical study sites and principal investigators.

• Develops and maintains professional relationships with assigned sites.

• Negotiates within approved parameters both investigator grant budget and contractual terms and conditions in accordance with client negotiation parameters, established process with clients and follows established escalation routes.

• Coordinates stakeholder review of changes outside of negotiation parameters and submission of recommendation to resolve negotiations.

• Monitors and reports contractual progress to Site Contract Manager.

• Partners to reduce and/or eliminate company regulatory, legal and financial exposure.

• Initiates and coordinates follow-up with stakeholders regarding the status of outstanding agreement issues in accordance with agreed process documents.

• Ensures that finalized contractual documents are uploaded  to eTMF within required timelines.

• Assists TMF specialist with eTMF QC and issue resolution in accordance with agreed process.

• Tracks common negotiation points for negotiation parameter updates in accordance with agreed process documents.

Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Associate Contract Specialist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

• Contract Specialist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years).

*Progressive and/or more extensive job duties and responsibilities may be expected with increasing Contract Specialist leveling. *

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.