Study Start-up Manager

Cambridge - UK

Monthly Salary: Not Disclosed

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

Career Category

Clinical

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel likeyourepart of something biggeritsbecause you are. AtAmgenour shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearchingmanufacturingand delivering ever-better products that reachover10 million patientsworldwide.Itstime for a career you can be proud of. Join us.

STUDY START-UPMANAGER

LIVE

What youwill do

In this vital role you willdrive the planning and execution of clinical study start-up activities ensuring trials are launched efficiently compliantly and to the highest quality standards.

The responsibilities of the role will include:

Lead the planning and delivery of clinical study start-up activities from global to local ensuring timelines quality budget and regulatory compliance are met.

Own and manage study start-up plans and milestonesmaintainingoversight of progress and resolving issues to keep delivery on track.

Act as the primary point of contact for cross-functional start-up teams driving clarity of roles accountability and collaboration.

Identify assess and mitigate risks proactively contributing to study risk assessments and ensuringtimelystudy start.

Partner closely with Study Delivery Leads managers and local teams providing clear updates solutions and escalation where needed.

Apply strong operational and regulatory knowledge (e.g. ICH-GCP submissions and start-up processes) to enable high-quality execution.

Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities.

Contribute to continuous improvement by sharingexpertise mentoring colleagues and developing best practices within the SSU hub.

WIN

What we expectofyou

We are all different yet we all use our unique contributions to serve patients.What weseekin you as anexperiencedprofessional are these qualifications and skills:

Degree educated

Clinical trial execution experience andpreviousexperience leadingpeople/teamsandworking inglobal teamsacross multiplegeographiesas well as project management experience

Experience with risk-based monitoring models / risk-based quality management and/or clinical site management

PMP Certification

THRIVE

What you can expectofus

As we work to develop treatments that take care ofothers sowe work to care for our teammates professional and personal growth and well-being.

Vast opportunitiestolearnand move up and across our global organization

Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act

Generous Total Rewards Plan comprising health finance and wealth work/life balance and career benefits

LOCATION:Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

for a career that defies imagination

In our quest to serve patientsabove all else Amgen is the first to imagine and the last to doubt. Join us.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

We will ensure that individuals with disabilities are provideda reasonableaccommodation toparticipatein the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to requestan accommodation.

Required Experience:

Manager

Career CategoryClinicalJob DescriptionHOW MIGHT YOU DEFY IMAGINATIONIf you feel likeyourepart of something biggeritsbecause you are. AtAmgenour shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborato...