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

Leading skill development of Local Study Operations Managers
Ensuring effective trial implementation within the country
Overseeing delivery of the country’s study portfolio
Managing scope, timelines, and budgets of studies
Overseeing LSOMs’ fulfillment of responsibilities from feasibility through study close-out
Monitoring portfolio progress and providing risk and quality oversight
Supporting issue escalation and resolution for LSOMs
Managing LSOM and LSOM vendor performance
Serving as primary escalation point for local study challenges
Mentoring, training, and supporting professional development of LSOMs
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
Evaluating risks, quality trends, and resource requirements
Implementing mitigation strategies and driving continuous improvement
Leading initiatives to enhance operational efficiency and sharing best practices
Managing resource allocation and workload distribution across LSOMs
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 clinical execution experience or Master’s degree and 6 years clinical execution experience or Bachelor’s degree and 8 years clinical execution experience or Associate’s degree and 10 years clinical execution experience or High school diploma / GED and 12 years clinical execution experience
Minimum 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation
7 years work experience in life sciences or medically related field
4 years 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

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 including 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, Amgen has helped pioneer the world of biotech in the fight against the world’s toughest diseases. With a focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – Amgen reaches millions of patients each year. The company researches, manufactures, and delivers innovative medicines to help people live longer, fuller, happier lives.