The World Leader In Serving Science
Senior Site Contract Specialist
Location
North Carolina
Posted
4 days ago
Salary
0
Seniority
Senior
Job Description
Senior Site Contract Specialist
Thermo Fisher Scientific
• Draft, review, negotiate and finalize agreements with study sites • Negotiate investigator grant budget negotiation parameters, contractual terms and conditions • Ensure compliance to established negotiation parameters, authority approval, and client expectations • Identify and assess legal, financial and operational risks • Provide recommendations and alternative resolutions to Investigator Contracts negotiations • Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual activities • Achieve target cycle times for site activations • Complete tracking and reporting as required • May provide training and mentoring to junior staff • Participate in country process improvement initiatives • Act as country subject matter expert in review of Investigator Contracts training materials • Liaise with Global Site Contracts to ensure compliance with established global processes
Job 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 5+ years)
- Detailed understanding of the principles of contract law
- Effective communication skills (verbal & written) in English and local language
- Detailed understanding and demonstrated ability to effectively negotiate investigator grant budgets
- Strong attention to detail
- Excellent analytical and decision based thinking skills
- Solid knowledge and 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
- Strong problem solving skills that are demonstrated via solid risk analysis that results in resolution or escalation as appropriate
Benefits
- Health insurance
- Professional development opportunities
- Flexible working arrangements
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• 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.
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