Biomedical Data Stewardship Manager

Location: Washington
Posted on: June 23, 2025

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Biomedical Data Stewardship Manager What you will do Lets do this. Lets change the world. Amgen is seeking a dynamic and experienced Biomedical Data Stewardship Manager to drive the design, implementation, and governance of standardized data collection practices across our clinical programs. In this vital role, you will build and manage case report form (CRF) libraries, develop implementation standards, and partner closely with cross-functional teams to ensure high-quality data collection that supports drug development success. You will also lead standards implementation for study teams through hypercare sessions, monitor and review use of standards, and facilitate governance processes. Key Responsibilities Design and define standard, indication-level CRF libraries using global standards-based and study-specific content and document implementation rules and decisions for their use in coordination with assigned subject matter experts. Design and review clinical data quality edit checks aligned with CRF content. Provide expert consultation and hypercare support to study teams in applying CRF library content and related tools. Monitor adoption and consistency of CRF standards, conducting audits and reviews to ensure alignment with evolving study and regulatory needs. Manage governance processes for evaluating and implementing updates or exceptions to CRF standards, including triage and adjudication of change requests. Coordinate with global standards governance bodies to ensure harmonized updates and compliant implementation across programs. Curate and manage standards content within a metadata repository (MDR), ensuring traceability, reusability, and consistency. Lead initiatives to expand data standards implementation across Amgens Global Development functions and external collaborations where applicable. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree Or Masters degree and 2 years of clinical experience Or Bachelors degree and 4 years of clinical experience Or Associates degree and 8 years of clinical experience Or High school diploma / GED and 10 years of clinical experience Preferred Qualifications: 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. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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, and 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 Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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