Amgen Senior TMF Operations Manager in Cambridge, United Kingdom

Senior TMF Operations Manager /Senior Development Operations Manager -TMF Operations

Amgen Global Clinical Program Management team are looking for an experienced TMF (Trial Master File) Senior Manager to support leadership for our TMF Operational strategy.

If you are looking for your next career step within TMF / Development Operations field 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/

Our Team:

The successful candidate will be part of the Global Clinical Program Management (GCPM) Trial Master File (TMF) team ensuring projects outsourced to Functional Services Provider are aligned to priorities and meet Amgen timeline, quality, data standards and compliance expectations.

Senior TMF Manager role overview:

As Senior Development Operations Manager - TMF Operations, you will support and guide strategy for TMF/Records Management advice consistent with global goals.

You will support resource planning activities as well as develop, mentor and coach team. As a Senior Manager, you will ensure operational efficiency and compliance with R&D Standards and training requirements

Responsibilities

  • Support leadership for TMF Operational strategy

  • Ensuring consistent, high quality Records Management advice for all Clinical Trial content

  • Manage and effectively allocate resources to meet project needs

  • Motivate and develop and mentor team, encouraging sharing of best practices and development of process improvements

  • Ensure team awareness and consistent following of current operating procedures

  • Maintaining business relationships cross-functionally within region and globally, status of TMF Ops accountabilities

  • Representing TMF Ops as appropriate, on process improvement initiatives, Development standards authorship or review

  • Lead and/or implement change initiatives in order to develop and improve departmental execution and effectiveness

  • Set goals and ensure delivery

  • Develop best practices for staff management and development through collaboration with other GDO line and functional managers

  • Develop and maintain robust relationships with internal and external experts and key global stakeholders

  • Identify and leverage external knowledge of industry best practices and processes

Basic Qualifications

  • Bachelor degree or equivalent

  • Strong experience of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reporting

  • Strong knowledge of GCP, external and internal regulatory requirements / guidelines

  • Experience of resource management and organisational capacity

  • Experience of developing goals, training plans to maximise team management and career development

  • Experience managing projects in a matrix organisation

  • Strong communication, negotiation and leadership skills

  • Solution orientated, driven to achieve results

  • Ability to network and build relationships to maximise organisational function and capabilities.

Location:

Cambridge, Uxbridge in UK or Thousand Oaks in US.

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 of $23 billion and nearly 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.