Local Study Operations Line Manager

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Amgen Kft.
Munkavégzés helye

Budapest

Munkaidő, foglalkoztatás jellege
- Alkalmazotti jogviszony
- Általános munkarend
Elvárások
- Angol középfok
- 3-5 év tapasztalat
- Középiskola

Állás elmentve

A hirdetést eltávolítottuk a mentett állásai közül.

Responsibilities

Leadership of Local Study Operations Managers skill development
Ensuring effective trial implementation within the country
Strong alignment with global strategies
Overseeing delivery of the country9s study portfolio management of scope, timelines, and budgets
Oversight of Local Study Operations Managers9 responsibilities from feasibility through study close-out
Monitoring portfolio progress, risk and quality oversight, and issue escalation support
Management of Local Study Operations Managers and vendor performance
Serving as primary escalation point for local study challenges and driving solutions
Mentoring, training, and supporting professional development of Local Study Operations Managers
Building and maintaining a high-performing team
Facilitating collaboration between study strategy team and local study teams
Promoting cross-functional collaboration among country teams
Supporting study placement decisions based on country capabilities and growth potential
Proactive evaluation of risks, quality trends, and resource requirements
Implementation of mitigation strategies and continuous improvement in country operations
Leading initiatives to enhance operational efficiency and sharing of best practices
Managing resource allocation and workload distribution across Local Study Operations Managers
Ensuring adherence to regulatory and quality standards
Collaborating with and supporting the country head in stakeholder engagement and escalation management

Requirements

Doctorate degree and 2 years of clinical execution experience
Master9s degree and 6 years of clinical execution experience
Bachelor9s degree and 8 years of clinical execution experience
Associate9s degree and 10 years of clinical execution experience
High school diploma or GED and 12 years of clinical execution experience
Minimum 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation

Nice-to-have

7 years work experience in life sciences or medically related field
4 years of biopharmaceutical clinical research experience in biotech, pharmaceutical or CRO company
Experience managing multiple teams or direct reports across multiple clinical functions or trials
Experience at or oversight of clinical research vendors such as CROs, central labs, imaging vendors
Experience managing clinical operations across relevant geography or region
Strong understanding of local regulatory requirements around global clinical trials

What we offer

Competitive benefits
Total Rewards Plan based on eligibility
Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities

Company info

Since 1980, we9ve helped pioneer the world of biotech in our fight against the world9s toughest diseases. With our focus on four therapeutic areas 6Oncology, Inflammation, General Medicine, and Rare Disease 6 we reach millions of patients each year. As a member of the Amgen team, you9ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.