Summarized Purpose :
Prepares and negotiates contracts, as well as, finalizes the contract process. Liaises and establishes effective relationships with sites and internal functional teams.
Ensures quality, objectivity and risk analysis in the efficient delivery of contracts.
Essential Functions :
Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local / accepted process
Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes
Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations
Ensures compliance of budgetary guidance, templates and process
Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes
Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels
ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation
Achieve target cycle times for site activations
Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
Bachelor's degree in law or equivalent and relevant formal academic / vocational qualification
Previous legal experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years’) or equivalent combination of education, training, & experience.
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job.
Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities :
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 and written) in English and in language spoken at local place of work
Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
Strong attention to detail
Excellent analytical and decision based thinking
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 and WPDs
Able to organize competing priorities logically and review outstanding contractual risk and issues
Able to effectively use automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc.
Ability to demonstrate a customer focused style of communication, problem solving and collaboration