Career Category
ClinicalJob Description
HOW MIGHT YOU DEFY IMAGINATION?
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.
Sr. 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.
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
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Senior Manager with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of directly related experience or
Master’s degree and 4 years of directly related experience or
Bachelor’s degree and 6 years of directly related experience or
Associate’s degree and 10 years of directly related experience or
High school diploma / GED and 12 years of directly related experience
Preferred Qualifications:
- 9 years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
- Previous management experience of direct reports
- Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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 provided 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 accommodation.
.Salary Range
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