BioSpace
Biomedical Data Stewardship Senior Manager
BioSpace, Thousand Oaks, California, United States, 91362
Overview
Biomedical Data Stewardship Senior Manager Join Amgen’s mission of serving patients. Amgen’s focus areas include Oncology, Inflammation, General Medicine, and Rare Disease, and we work to research, manufacture, and deliver innovative medicines that help people live longer, fuller lives. Our culture is collaborative, innovative, and science-based, with opportunities for challenges and growth. 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
Lead the designation and definition of 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. Lead the 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 Amgen’s 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 and 2 years of clinical experience Or Masters degree and 4 years of clinical experience Or Bachelors degree and 6 years of clinical experience Or Associates degree and 10 years of clinical experience Or High school diploma / GED and 12 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. Extensive 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 and 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 of us
We support your professional and personal growth and well-being through competitive benefits and a collaborative culture. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted; actual salary will vary based on skills, experience, and qualifications. Our Total Rewards Plan includes health and welfare plans, retirement/savings options, work-life balance, and career development opportunities. A comprehensive benefits package including retirement and savings, medical/dental/vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program (or sales-based incentive plan for applicable roles). Stock-based long-term incentives and award-winning time-off plans. Flexible work models, including remote and hybrid options where possible. Apply now and make a lasting impact with Amgen. We are committed to an inclusive environment and equal opportunity for all applicants. We will ensure reasonable accommodations are provided upon request during the job application or interview process. Equal Opportunity Employer. We will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. Location
Santa Monica, CA
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Biomedical Data Stewardship Senior Manager Join Amgen’s mission of serving patients. Amgen’s focus areas include Oncology, Inflammation, General Medicine, and Rare Disease, and we work to research, manufacture, and deliver innovative medicines that help people live longer, fuller lives. Our culture is collaborative, innovative, and science-based, with opportunities for challenges and growth. 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
Lead the designation and definition of 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. Lead the 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 Amgen’s 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 and 2 years of clinical experience Or Masters degree and 4 years of clinical experience Or Bachelors degree and 6 years of clinical experience Or Associates degree and 10 years of clinical experience Or High school diploma / GED and 12 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. Extensive 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 and 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 of us
We support your professional and personal growth and well-being through competitive benefits and a collaborative culture. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted; actual salary will vary based on skills, experience, and qualifications. Our Total Rewards Plan includes health and welfare plans, retirement/savings options, work-life balance, and career development opportunities. A comprehensive benefits package including retirement and savings, medical/dental/vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program (or sales-based incentive plan for applicable roles). Stock-based long-term incentives and award-winning time-off plans. Flexible work models, including remote and hybrid options where possible. Apply now and make a lasting impact with Amgen. We are committed to an inclusive environment and equal opportunity for all applicants. We will ensure reasonable accommodations are provided upon request during the job application or interview process. Equal Opportunity Employer. We will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. Location
Santa Monica, CA
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