Amgen—Data Acquisition Lead- eConsent

Job description

Description: Career Category Clinical Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Data Acquisition Lead - eConsent What you do Let’s do this. Let’s change the world. In this vital role you will lead the acquisition, integration, and quality management of non-CRF (external/supplier) clinical trial data and associated clinical systems, ensuring they are timely, accurate, and fit-for-purpose to support study delivery and analytics, with regulatory compliance. This role sits within the Data Management organization, and responsibilities will be assigned to you based on your experience and subject matter expertise to deliver systems and data quality across the clinical portfolio. - Own the design, setup, and ongoing management of non-CRF data and/or systems as assigned by management (e.g., central labs, imaging, wearables, precision medicine, IRT, eCOA, eConsent), ensuring seamless integration and traceability - Alignment of system requirements, setup and lifecycle activities with study protocol and eConsent requirements - Own, define and maintain supplier data transfer and/or system specifications, oversee system and data transfer agreements to ensure alignment to study requirements and study protocol including associated data flows, as applicable - Ensure timely and accurate ingestion of external datasets, proactively resolving formatting, mapping, and data quality issues – own query resolution with data including issue escalation with study team and/or suppliers including reconciliation and resolution of eConsent-related data or integration discrepancies, as applicable - Partner with other Data Management roles, Clinical Systems partners, external service providers, and the study team (global/local) to ensure external systems and data align with study protocol, regulatory requirements and Clinical Trial Database CRF structures, and data is accessible within EDC or other data platforms for downstream processes including data cleaning and archival including and traceability of eConsent systems and associated data - Lead troubleshooting of supplier system and/or integration issues, including delayed or inconsistent data deliveries, missing data and escalate issues and systemic risks as needed including eConsent system, configuration, data flow - Monitor the quality of system documentation and/or incoming data throughout the study lifecycle and initiate early reconciliation to prevent downstream delays or risks to inspection readiness – ensure we are ‘data delivery/analysis’ ready at all times including monitoring eConsent system/data quality, traceability, and reconciliation, as applicable - Support the internal team by managing task or project-related timelines against study milestone targets to ensure no impact to system lifecycle activities or other deliverables including eConsent setup, updates, and study amendment-related activities - Work with internal or external resources to manage the creation and execution of user acceptance testing, deployment, and change control activities for systems and/or integrations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications. Basic Qualifications: Doctorate degree OR Master’s degree OR Bachelor’s degree with 8 - 12 yrs experience. Preferred Qualifications: - 5 years’ work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience responsible for clinical systems and/or data acquisition delivery on clinical trials in a biotech, pharmaceutical or CRO / supplier company - Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials - Experience in management and oversight of external suppliers (e.g., eConsent, CROs, central labs, imaging, IRT, eCOA, etc.) - Knowledgeable in Good Clinical Practices, electronic records and electronic signatures requirements, and regulations governing clinical trials and informed consent - Experience with clinical system integrations, data flows, validation, and change control - Project management and technical expertise, attention to detail, and excellent documentation and communication skills - Meeting management and facilitation skills - Excellent time management and organization skills in a fast-paced environment - Sound problem resolution, judgment, and decision-making abilities - Ability to work well in a team-based environment with minimal supervision 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising 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: - 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 and bi-annual company-wide shutdowns - Flexible work models, including remote work arrangements, where possible. .