Career Category
ClinicalJob Description
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Senior Manager, Clinical Program Management (CPM-SM) – Observational Research
LIVE
What you will do
In this vital role, the CPM-SM in Observational Research (OR) will apply program management knowledge and Real-World Evidence experience as an operational lead overseeing the planning, design, execution, risk assessment and mitigations of several inhouse and/or fully outsourced observational research studies. These evidence generation studies span across all TAs and include various study types, complexities and novel operational models. A Senior Manager in CPO-OR is responsible for line management and maintaining close collaboration and alignment with internal stakeholders, such as: TA, Global Medical, CfOR, Operational and Safety stakeholders and external vendors and collaborators. In addition, the CPM-SM is consistently assessing the need for more fit for purpose processes to reflect innovative real world study designs and data collection methodologies.
Additional responsibilities:
Oversee people management, career development, training and succession planning of Amgen GTMs supporting the Observational Research Portfolio
Support CPO resource planning for Observational Research portfolio in collaboration with CPO/OR Director, PRM and FSP Partners
Oversee the operational execution, design, planning, risk assessment and mitigations of assigned inhouse and fully outsourced observational research studies.
Oversight of assigned OR study specific budgets including change control in collaboration with TA Governance and Finance
Point of issue escalation for Clinical Study Team on assigned studies.
Ensure strong relationships and alignment with TA, GSO, CfOR, Safety, and HE representatives, maintaining and improving global collaboration and consistency
Providing clinical operations leadership and expertise on the Product Teams (PTs) and AUEG (Access and Use Evidence Generation) Teams, as requested
Support the identification of outsourcing requirements and the evaluation, selection, setup, and management of vendors for observational studies
Contribute operational expertise ensuring operational feasibility throughout study design process, including KDE and Protocol Development
Provide advice as requested on core study documents prior to Governance Body review
Lead the Country Operational Landscape Assessments and study feasibility with Feasibility Director (study level) for inhouse managed observational research studies.
Oversee and approve study global enrolment baselines and accurate global recruitment forecasting.
Review and input into SOPs, Work Instructions, FORMS, templates and training for which CPO-OR are a stakeholder.
Supporting continuous improvement initiatives in Clinical Program Operations (CPO) and Global Development Operations (GDO)
Support and coordinate audit and inspection activities and contributes to CAPAs ensuring the update of processes.
Communicate effectively with key team members to ensure operational strategy alignment.
Contribute to functional goal setting as member of CPO-OR Leadership team and respective study level goals
BE PART OF OUR TEAM
We are a high performing team of CPMs with operational oversight and leadership of GTMs and LTMs, working cross-functionally in a team/matrix environment on multiple projects.
WIN
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
PhD, MSc or BA in life science, computer science, business administration or related discipline
Extensive experience of Global Clinical Trial Management
Experience across phases I – IV preferred
Previous management experience of direct reports
Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Project management and planning experience
LOCATION: This role will accept applicants from UK and US.
THRIVE
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and 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
APPLY NOW
Objects in your future are closer than they appear. Join us.
careers.amgen.com
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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