Biomedical Data Stewardship Manager

Job not on LinkedIn

November 21

Apply Now

Receive Emails with Similar Jobs

Amgen

WebsiteLinkedInAll Job Openings

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.

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

📋 Description

• Drive the design, implementation, and governance of standardized data collection practices across our clinical programs • Build and manage case report form (CRF) libraries • Develop implementation standards • Partner closely with cross-functional teams to ensure high-quality data collection that supports drug development success • Lead standards implementation for study teams through hypercare sessions • Monitor and review use of standards • Facilitate governance processes • Curate and manage standards content within a metadata repository (MDR) • Lead initiatives to expand data standards implementation across Amgen’s Global Development functions and external collaborations where applicable.

🎯 Requirements

• Doctorate degree or Master’s degree and 2 years of clinical experience or Bachelor’s degree and 4 years of clinical experience or Associate’s degree and 8 years of clinical experience or High school diploma / GED and 10 years of clinical experience • Degree in a related field such as statistics, biostatistics, life sciences, programming, computer science, or business administration • 5+ years cumulative experience in data management, biostatistics, or clinical programming within the pharmaceutical or biotechnology industry • 3+ years of experience in a global, matrixed organization • Proven experience with CRF design, data standards governance, and clinical metadata repository (MDR) tools • Experience in data collection, analysis, and reporting within drug development and clinical trial processes as well as utilizing metadata repository systems to curate and maintain standards-related assets • Strong skills in project planning, stakeholder engagement, process improvement leadership, documentation development, training, and compliance • Proven ability to collaborate effectively build relationships on global cross-functional teams • Effective written and verbal communication, facilitation, and negotiation skills with all levels within the organization • Demonstrated success in SOP development and regulatory-compliant documentation practices • Proficient in the use of software and data applications relevant to drug development.

🏖️ Benefits

• A 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 • stock-based long-term incentives • Award-winning time-off plans