Senior Manager Clinical Data Management

Category: Clinical
Job ID: R-65642
Employment Type: Full time
Location: United Kingdom – Cambridgeshire; United Kingdom – Uxbridge; US – California – South San Francisco; US – California – Thousand Oaks
Posted Date: November 8, 2018

Senior Manager Clinical Data Management

Amgen Clinical Data Management team is looking for an experienced Senior Clinical Data Management Manager who will be responsible planning and oversight of all Data Management activities within the global team.

If you are looking for your next career step within Clinical Data Management and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/

Senior Manager Clinical Data Management role overview:

The Senior Manager Clinical Data Management plans and oversees the implementation of Data Management (DM) key activities including leadership of multiple projects or DM product teams.

Participate in setting vision and strategy for DM and provide senior level supervision, support and management of DM employees.

Responsibilities

  • Oversight of a core DM Group
  • Management and development of DM employees within the core group
  • Assisting with recruitment of DM employees
  • Resource and budget planning for this core group
  • Planning, leading and overseeing DM activities for assigned products / projects
  • Contribute to and assist in the implementation of DM and the wider Global Study Operations Strategy
  • Provide technical and business expertise and leadership in process improvement activities and emerging technologies
  • Ensuring DM processes/systems meet regulatory and business requirements
  • Contribute to and dive forward the strategic direction of DM globally
  • Lead and/or participate in cross functional working groups
  • Develop, review and implement policies, SOPs and associated documents affecting DM globally
  • Assist in responding to audit findings
  • Define and maintain SLAs and KPIs, including oversight or quality and CAPA management
  • Monitor progress of clinical projects, ensuring all are executed according to timelines with quality

Basic Qualifications and preferred experience:

  • Bachelors degree or equivalent in life science, computer science, business administration or related discipline
  • Broad and proven experience in life sciences or a medically related field including experience in biopharmaceutical clinical research experience
  • Previous line management experience
  • Extensive Data Management experience in a global organisation
  • Previous experience at or oversight of outside clinical research vendors (CRO’s, central Labs, vendors, etc..)
  • Knowledge of Good Clinical Practice, Drug development and clinical trials processes, clinical trial databases and applications, Quality Management, Regulatory filings and inspections, Risks analysis, Process improvement methodologies is essential

Location: Cambridge, Uxbridge, Thousand Oaks or San Francisco

Remuneration:

Competitive salary & comprehensive benefits package including bonus scheme

The company:

Amgen is one of the world’s largest independent biotechnology companies, with global revenue in excess of $20 billion and over 20,000 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 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.

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