Clinical Data Mgmt Manager
About The Position
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. Clinical Data Mgmt Manager What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will:
Requirements
- Bachelor’s degree (or foreign equivalent) in Business Administration or related field & 3 years of experience in the job offered or in a clinical data management-related occupation.
- Position requires 3 years of experience in the following: 1. Developing and implementing data management plans (DMP) for clinical trials, including data collection, validation, and quality control strategies; 2. Overseeing the design and development of electronic case report forms (eCRFs) and clinical trial databases; 3. Leading data cleaning activities to rectify identified issues and discrepancies; 4. Ensuring data management activities comply with regulatory guidelines, including Good Clinical Practice (GCP) and CDISC standards; 5. Preparing and contributing to regulatory submissions and audits; 6. Collaborating with cross-functional teams, including clinical researchers, biostatisticians, and clinical monitors, to ensure data quality and accuracy; and 7. Performing documentation and archival in electronic Trail Master file (eTMF).
Responsibilities
- Ensure a focus on timely quality delivery, as well as consistency across the Data Manager (DM) components
- Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
- Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
- Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners and external vendors
- Promote and be an advocate of DM internally and externally
- Communication and escalation of project level issues including processes, timelines, resourcing, performance
- Assist with response to questions and findings from Clinical Quality Assurance and other audits at the study and vendor level.
Benefits
- stock
- retirement
- medical
- life and disability insurance
- eligibility for an annual bonus or for sales roles, other incentive compensation
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
