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Global Clinical Program Management Sr. Manager
3 months ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our 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 togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Global Clinical Program Management Sr. Manager - Observational Research (US based)Live
What you will do
Lets do this. Lets change the world. In this vital role you will coordinate and oversee the operational strategy, planning, risk assessment and mitigation, and overall execution of observational research studies within CPO-OR (Observational Research).Responsible for:
- 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 observational research (OR) studies
- Oversight of assigned OR study budgets including change control in collaboration with TA Governance and Finance.
- 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) Key Evidence Generation Teams (KEGs) and Evidence Generation Teams (EGTs) as requested.
- Support the identification of outsourcing requirements and oversee 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)
- Oversee and approve study global enrollment baselines and accurate global recruitment forecasting
- Support fit for purpose OR operating model by identifying process gaps or improvements with the development of new processes, authoring. Review of SOPs, Work Instructions, FORMS, templates and training.
- Support and coordinate audit and inspection activities and contributes to CAPAs ensuring the update of processes where vital and appropriate verifications.
- Communicate effectively with key team members to ensure operational strategy alignment and contribute to functional goal setting within the program.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a driven individual with these qualifications.Basic Qualifications:
- Doctorate degree & 2 years of life sciences or medically related field OR
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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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.
