FSP 顾问合同专员/合同专员

Job Title: FSP Associate Contract Specialist/Contract Specialist
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 issuesin 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 resolutionin accordance with agreed process.

• Tracks common negotiation points for negotiation parameter updatesin 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.

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Originally posted on Himalayas