♦ Associates degree. Bachelor's degree in Life Sciences, Business Administration or related discipline preferred.
♦ 3 years experience within the Pharmaceutical Industry and a detailed knowledge/understanding of the clinical development processes
♦ A proven track record of contract management (Pharma.) or Business/Proposal Development (CRO/Legal)
♦ Demonstrated ability with respect to time management, experience with conducting negotiations, influencing, analytical, problem solving and facilitation skills within the pharmaceutical or CRO industry
♦ Effective communication skills, with the ability to build relationships at all levels, across many disciplines both internally and externally
♦ Demonstrated ability to effectively interact with demanding clients/suppliers and undertake conflict resolution.
♦ Clinical research experience (Phase 2-4) is desirable
♦ Financial analysis experience is desirable, including a track record of budget management, contract financial analysis, evaluation of pricing models and negotiation of the financial aspects of contracts
♦ Knowledge and/or experience of costing for Investigator contracts are desirable
♦ Develop and negotiate investigator contracts and contract amendments that are robust, timely and add significant opportunity for value generation to the business while minimising risk
♦ Effectively explore alternatives and positions to reach outcomes that gain all parties' support and acceptance
♦ In consultation with client groups, develop detailed specifications, analyse resulting proposals (for both service and cost provisions) and negotiate (both costs and content) contracts and contract amendments
♦ Independently (or with some supervision) ensure that all negotiation of contractual terms and conditions are based on approved GSK Vx Clinical Study Agreement templates (M/SSUA, MSA/SSA, CSA)
♦ Liase with functional groups to determine/define the scope of contract services required; identify & facilitate resolution of all business and legal issues
♦ Ensure GSK policies are adhered to w.r.t. appropriate authorisation and routing of contracts, ensuring the production, distribution and document management occurs
♦ Responsible for the ongoing contract management (with assistance from a Senior colleague if needed) including Changes in Scope, Conflict resolution and Reconciliation of all assigned contracts
♦ Involvement and responsibilities with the development of tracking systems related to external costs
♦ Review, provide comments on and assist with the development of training materials to help acquaint GSK staff in the procedures used for contract development
♦ Serve as liaison between GSK and external suppliers on contractual issues; identify and proactively raise issues and concerns in a timely, open and appropriate manner and develop recommendations for resolution
♦ Assist with development and implementation of strategies for increasing efficiencies in outsourcing
♦ The scope of this job crosses all therapeutic areas and requires effective communication across all levels of the business as well as external parties. Internally this includes Study Managers, Heads of Clinical Operations, Clinical Development Managers/Medical Monitors responsible for the conduct of clinical trials, CRAs, CSAs, Legal, Finance and Benchmarking. Externally this includes investigators as well as finance and/or legal staff from investigator sites/institutions.
♦ This diverse client base requires someone with a solid understanding of the clinical development process, the clinical budget process, the per-subject budget and benchmarking process and the knowledge of their interrelationship and impact.
♦ Requires keen analytical and problem solving skills as well as the ability to react quickly in an ever changing environment where stakeholder demands are high
♦ Ability to work under extremely tight timelines and to work simultaneously across multiple therapeutic areas
You may apply for this position online by selecting the Apply now button.
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