Study Start-up Manager

🔥 3 hours ago

🇺🇸 United States – Remote

💵 $122.2k - $150.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

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

• Drive the planning and execution of clinical study start-up activities, ensuring trials are launched efficiently, compliantly, and to the highest quality standards • Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met • Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track • Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration • Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start • Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed • Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution • Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities • Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub

🎯 Requirements

• Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required • Requires experience leading and managing global teams and project management experience • No prior Veeva experience required • Doctorate degree OR Master’s degree and 3 years of clinical execution experience OR Bachelor’s degree and 5 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR High school diploma / GED and 12 years of clinical execution experience • Must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company • Experience working in global clinical trial teams across multiple geographies • Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management • PMP Certification

🏖️ 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. • 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