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Senior Manager Study Management - United Kingdom  

Amgen (company)


Posted on : 01 May 2017

Project Description

About Us:
  • Our company 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, our company  has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient.  
  • Our company  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 responsibilities
  • The Sr. Manager, Study Management 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 EA
  • Oversee regional cross-functional NASCR activities, identifying and resolving issues for global standardisation
  • Partner with NASCR Director and counterpart Sr. Manager(s) to ensure global alignment and standardisation in process
  • Act as regional subject matter expert in global process standardization and process improvement initiatives
  • Oversee/facilitate resolution of cross-functional study specific issues
  • Establish and maintain global cross-functional business relationships
  • Establish and maintain internal and external client/customer satisfaction
  • Ensure regional NASCR supported in accordance with global ISS SOP, EA MAN and other supporting documentation
  • Oversee or input into regional NASCR resourcing to meet demand
  • Participate in standards authorship or review
  • Manage and/or mentor NASCR regional and local staff, as applicable
  • Escalate issues, as appropriate, to Director NASCR, and either lead or support resolution
  • Collaborate within global NASCR group, and within cross functional matrix

Basic Qualifications:
  • Bachelor’s degree in relevant discipline, or RN
  • Broad 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 Qualifications
  • BA/BS/BSc in the sciences or RN
  • In-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 company
  • Previous management experience of direct reports
  • Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.)
  • Experience across therapeutic areas and products
  • Knowledge of international regulatory requirements
  • Experience with processes relating to externally sponsored studies (Investigator Initiated Studies) and Expanded Access
  • Experience of clinical operational issues, process and procedures
  • Experience collaborating & leading cross functional teams (team matrix environment)
  • Experience writing and presenting clearly on clinical operational issues
  • Experience working internationally/globally
  • Excellent Interpersonal, organisational, and supervisory skills