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Amgen Trial Master File (TMF ) Operations Manager in Cambridge, United Kingdom

Amgen, Trial Master File (TMF) Operations team are looking for an experienced individual with a Clinical Trial background who has been involved with management of records for the Trial Master File (ICH GCP requirement). We are seeking a proactive individual, with a ‘can do’ attitude who will support clinical trial study teams ensuring, a contemporaneous TMF at all times in line with Inspection Readiness.

This individual will provide records management advice including management of individual projects in line with the function strategy and will identify, manage, escalate and resolve issues related to records management.

If you are looking for your next career step within the bio-pharmaceutical 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 http://careers.amgen.com/uk-ireland

Your TMF Operations Team is located in the UK and US and work with several functional service providers across the business to support TMF activities for clinical trials within Global Clinical Program Management (GCPM), spanning both interventional and observational trials.

TMF Operations Manager role overview:

Support Clinical Trial Study teams and provide TMF expertise.

Expected to be an expert in this area including system knowledge and identify future opportunities in regard to industry/regulatory changes.

Represent Line Manager as required

Implement strategy for TMF records management advice consistent with global goals

Establish and maintain collaborative relationship with TMF vendors and customers.

Responsibilities:

Global role in Global Development Operations (GDO) based in UK

Responsible for:

Deliver consistent, high quality Records Management advice for all Clinical trial content to ensure compliance including in-house and outsourced studies encompassing multi phases.

Mentoring staff to ensure awareness and consistent following of current operating procedures and best practices.

Maintaining business relationships cross-functionally within region and globally.

Representing TMF operations as appropriate on process improvement initiatives.

Development of standards, authorship or review.

Implement change initiatives in order to develop and improve departmental execution and effectiveness.

Develop knowledge of best practices and process improvements.

Qualifications and ideal required experience:

Bachelor’s degree & 5 years of related experience

(5 years work experience in life sciences or medically related field, including knowledge of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Management experience of staff reports for oversight

Proven experience and skills needed:

5 years work experience in life sciences or medically related field, including knowledge of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Electronic TMF experience

Project management skills with proactiveness and ownership

Relationship Building

Strong Written and Oral communication

Scientific/Technical Excellence

Flexibility/Adaptability

Location: Uxbridge or Cambridge

Remuneration:

Competitive salary & comprehensive benefits package including bonus scheme

About our 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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