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Senior Manager Study Management Uxbridge United Kingdom,  


Posted on : 01 May 2017

Project Description

Title: Senior Manager, Study Management (Non-Amgen Sponsored Clinical Research)Duration of role: PermanentLocation: Uxbridge, UKAbout Amgen Amgen is one of the world s largest independent biotechnology companies, with a global turnover in excess of $20 billion and over 18,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen discovers and develops innovative human therapeutics and also supports unsolicited external proposals to advance clinical medicine by collaborating with qualified Investigator Sponsors who generate promising ideas in areas of mutual scientific interest.Key responsibilitiesThe Sr. Manager, Study Management (Non-Amgen Sponsored Clinical Research [NASCR]) oversees and manages operational activities related to the planning, implementation, and reporting of NASCR. The role is part of the Global Development Operations (GDO) group and reports to the Director of Study Management, NASCR. The role will also oversee the support of Investigator Sponsored Studies (ISS), other NASCR, and Expanded Access (EA), ensuring global standardization, according to applicable SOPs and plans.Specific responsibilities for the role include, but are not limited to:Oversee regional planning, management, and reporting of NASCR including ISS, Co operative group ISS, Research Partner Studies and EAOversee regional cross-functional NASCR activities, identifying and resolving issues for global standardisationPartner with NASCR Director and counterpart Sr. Manager(s) to ensure global alignment and standardisation in processAct as regional subject matter expert in global process standardisation and process improvement initiativesOversee/facilitate resolution of cross-functional study specific issuesEstablish and maintain global cross-functional business relationshipsEstablish and maintain internal and external client/customer satisfactionEnsure regional NASCR supported in accordance with global ISS SOP, EA MAN and other supporting documentationOversee or input into regional NASCR resourcing to meet demandParticipate in standards authorship or reviewManage and/or mentor NASCR regional and local staff, as applicableEscalate issues, as appropriate, to Director NASCR, and either lead or support resolutionCollaborate within global NASCR group, and within cross functional matrixBasic Qualifications:Bachelor s degree in relevant discipline, or RNBroad experience in life sciences or medically related field, including general knowledge of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical company or CRO)Preferred QualificationsBA/BS/BSc in the sciences or RNIn-depth experience in life sciences or medically related field, including thorough knowledge of biopharmaceutical clinical research experience obtained at either at a Sponsor Institution, Academic Centre or working on clinical trials at a biotech, pharmaceutical or CRO companyPrevious management experience of direct reportsExperience in oversight of outside vendors (CRO s, central labs, imaging vendors, etc.)Experience across therapeutic areas and productsKnowledge of international regulatory requirementsExperience with processes relating to externally sponsored studies (Investigator Initiated Studies) and Expanded AccessExperience of clinical operational issues, process and proceduresExperience collaborating & leading cross functional teams (team matrix environment)Experience writing and presenting clearly on clinical operational issuesExperience working internationally/globallyExcellent Interpersonal, organisational, and supervisory skillsAmgen is an equal opportunities employer

Locations

United Kingdom Uxbridge

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