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Global Study Operations (GSO) -Clinical Data Management Manager United Kingdom,  

Amgen (company)

Posted on : 01 May 2017

Project Description

The company:
  • Our company is one of the world s largest independent biotechnology companies, with global revenue in excess of $18 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  has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

The role:
  • The GSO-Data Management (GSO-DM), Manager (Project Lead) role will partner with cross functional study teams as well as our functional service provider (FSP) to ensure product delivery of the company  Therapeutic Area (TA) portfolio. 
  • This individual will focus on oversight of their portfolio with the FSP, ensuring delivery of studies per the timelines is met and data is fit for purpose .    
  • Reporting into the GSO-DM Senior Manager, this key role will be collaborating with a variety of business functions and will offer a strong commitment to serving customers both inside and outside of Global Study Operations (GSO).
  • This individual will present updates/project status within GSO-DM and cross functional team  meetings etc. as required.
  • This individual will ensure a focus on timely quality delivery as well as consistency across the Data Manager components, whilst ensuring the company culture and values are at the forefront of their actions.

Responsibilities include:
  • Development:
    • Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting Data Management, including
    • cross functional working groups
    •  Contribute to the continuous improvement of Data Management and the wider Development organization through, training and mentoring of staff and  information sharing and education
    • Develop and co-ordinate project level training for data management staff
    • Contribute to development of Data Management outsourcing strategies and long-term relationships with CRO partners / external vendors
  • Projects:
    • Represent Data Management at project team meetings, cross functional team meetings
    • Project level coordination of, and day to day oversight of Data Management tasks including; coordinating with lead data managers and managing vendor deliverables, reviewing of documents to ensure consistency and that system quality control checks are being completed.
    • Review project timelines and metrics to ensure databases are delivered to set timelines to include communication and escalation of any project level issues
    • Lead electronic submission activities
    •  Assist with responses to questions and findings from Clinical Quality Assurance  and other audits at the study / vendor level

Basic qualifications:
  • Relevant Bachelor s degree
  • Solid experience in/knowledge of data management in a pharma/biotech/CRO arena
  • Proven project management/lead and planning experience
  • Demonstrated experience working effectively in cross-functional teams
  • Experience in oversight of outside vendors including Functional Service Provider (CRO s, central labs, imaging vendors, etc.)
  • Strong communication, negotiation and leadership skills
  • Solution orientated, driven to achieve results both decisively and efficiently

Preferred Qualifications and Experience:
  • Bachelor s degree or equivalent in life science, computer science, business administration
  • Experience in RAVE EDC will be highly regarded
  • Experience in working in a global outsourced environment


United Kingdom Cambridgeshire; United Kingdom Uxbridge

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