FSP Associate – Contract Specialist
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Site Contract Specialist preparing and negotiating contracts in clinical trials, collaborating with pharmaceutical companies and biotechs. Ensuring compliance and quality in contract processes across multiple studies.
Responsibilities:
- 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.
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).
- 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
Benefits:
- Health insurance
- Professional development opportunities
Similar Jobs
Contract Specialist – FSP
Site Contract Specialist preparing and negotiating clinical trial contracts. Collaborating with cross-functional teams to ensure quality and timely deliverables.
Senior Site Contract Specialist
Senior Site Contract Specialist at Thermo Fisher managing contract preparation, negotiation, and compliance with study sites. Liaising with teams and mentoring junior staff.
Contract Specialist, Senior Contract Specialist
Contract Specialist managing high-value contracts for clinical trials at Thermo Fisher Scientific. Drafting, negotiating, and ensuring compliance in a remote role based in Germany.
No more related jobs available.