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/
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
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
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.
Cambridge, Uxbridge in UK or Thousand Oaks in US.
Competitive salary & comprehensive benefits package including bonus scheme
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.