Pharmaceutical Clinical Associates, LLC
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San Francisco,
CA
The Clinical Site Contracts and Budget manager’s primary responsibilities shall include but are not limited to the preparation, negotiation, tracking and finalization of the clinical trial agreements and confidentiality agreements inclusive of the site budget within the clinical trial agreement. This position reports to the Associate Director, Clinical Contracts and Outsourcing.Specific duties include but are not limited to:
* Draft, negotiate and track status of clinical trial agreements, amendments, advisory consulting agreements, bioanalytical and confidentiality agreements with site specific information and e-mail to sites/consultants/service providers
* Status the relevant parties regarding outstanding agreements and budgets, and provide weekly updates to clinical team
* Process all agreements for execution, ensuring that the appropriate departments within FibroGen receives a copy
* Assist in bioanalytical outsourcing
* Prepare benchmarking data to substantiate the site budget templates
* Develop a proposed budget range for management with respect to site budget templates
* Prepare documentation for obtaining budget approval from Senior Management
* Ensure that all budget approvals, correspondence, invoices and fully executed contracts are filed within the clinical contracts filing system and ensure files are audit ready
* Track all fully executed clinical agreements and invoices
* Update the financial spreadsheets for each study/site
* Liaise with clinical for monthly site accruals
* Pay, track and reconcile all payments to investigator sites
* Responsible for the development of site budget templates from the Schedule of
* Assessments
* Liaise with legal for review of contract language
* Mentor Clinical Contract Associates and may have a supervisory role
* Negotiate global clinical trial agreements and budgets
* Establish, draft and train with respect to process documents
Internal Notes:
Experience and Skills:
Job Requirements:
* BS/BA in Business Administration, finance or related discipline, or equivalent education plus experience
* Minimum of (5) years of site budget and contract negotiation experience
* Minimum of 7-9 years of experience in a contract administration environment in a pharmaceutical, CRO or biotech company
* Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts (healthcare compliance, GCP, CFR)
* Excellent negotiation and written/verbal communication skills
* Ability to work independently, creative thinking and problem solving skills
* Ability to understand the full clinical development process
* Must understand the “Sponsor of Choice” philosophy
* Must have good organization and planning skills, proven ability to handle multiple priorities and work independently
* Must be a team player and be a leader within the department
* Proficiency with MS Word, Excel, Access and Outlook required
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
San Francisco, CA
San Francisco, California
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