Local Study Operations Manager – TA Head

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $167.2k - $226.2k / year

⏰ Full Time

🔴 Lead

⚙️ Operations

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This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Lead and develop Local Study Operations Senior Managers • Ensure accountable delivery of the country’s study portfolio • Oversee portfolio scope, timelines, budgets, quality, and efficiency • Provide strategic direction for portfolio monitoring, local action plans, and issue resolution • Serve as the primary escalation point for complex or systemic local study challenges • Build and maintain a high-performing LSOM leadership team • Facilitate collaboration between global study strategy teams and local study teams • Coordinate country functional teams for successful portfolio delivery • Support country study placement discussions and advise on site selection and resource allocation • Support country-level risk assessments and manage delivery risks • Ensure inspection readiness and provide hands-on inspection support, including responsibility for storyboards • Promote continuous operational improvement, digital innovation, and best-practice sharing • Manage resource allocation and workload distribution among LSOM Senior Managers and the broader LSOM team, including FSP and FTE • Ensure compliance with regulatory and quality standards • Collaborate with the country head and cross-functional stakeholders to align trial deliverables and manage escalations

🎯 Requirements

• Doctorate degree and 3 years of clinical execution experience OR Master’s degree and 7 years of clinical execution experience OR Bachelor’s degree and 9 years of clinical execution experience OR Associate’s degree and 12 years of clinical execution experience OR High school diploma / GED and 14 years of clinical execution experience • Minimum of 3 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • +8 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience (preferred) • Experience managing multiple teams / direct reports (preferred) • Experience at or oversight of outside clinical research vendors, including CROs, central labs, and imaging vendors (preferred) • Experience working on global clinical trials (preferred) • Track record of improving site engagement, investigator relationships, and operational efficiency (preferred) • Highly effective communication skills (preferred)

🏖️ Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • 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 • Career development opportunities • Work/life balance support