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更新于 4月9日

合同專員 ID182158

1-2萬
  • 廣州越秀區(qū)
  • 六榕
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

合同談判
Overview: Prepare, negotiate and finalize agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.
Deliverables: - Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc. - Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements. - Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate. - Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and pricing guidelines. Participate in and/or lead approval escalations as appropriate. - Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required. - Participate in discussions related to the development of site/investigator budgets aligned with fair market value. - Manage the contract amendment lifecycle. - Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate. - Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. - Assume responsibility for all aspects of legal document and metrics tracking. - Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines. CCS management and functional CCS support teams such as, legal, Healthcare Compliance (HCC), Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate. - Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle. - Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. - Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GCDO and operating companies. Comply with requests from QA and auditors. - Full utilization by timely and accurate time reporting (BEACON). - If applicable, region-specific deliverables will be specified. - Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. SATS) according to expectations (metrics) and archiving retention requirements. - Ensure inspection ready and comply with relevant training requirements and developing therapeutic knowledge to ensure service delivery.
Advanced: o Analyze contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are following corporate process, systems, and strategies. o May mentor, champion, or represent functional area in process initiatives, as required. o Autonomy with execution of CCS services. o Depth of knowledge with CCS services. o Process leadership. o Region specific activities (to be specified).
Requirement: - 2-8 years work experience, prefer with MNC background - Clinical research experience or contract related experience in other industry with good learning ability - English is workable, plus master the language of either Japanese or Korean at business level

工作地點(diǎn)

廣州越秀區(qū)新寶利大廈中山六路2號(hào)1005室

職位發(fā)布者

黃朔/招聘經(jīng)理

剛剛活躍
立即溝通
公司Logo愛恩康臨床醫(yī)學(xué)研究(北京)有限公司
At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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