Senior Manager, Data Management Process Excellence

Career Category

Clinical Development

Job Description

Role Name: DM Process Specialist Sr Manager

Department Name: Global Development Operations

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

The Senior Manager, DM Process Specialist, is responsible for driving process excellence, standardization, and operational effectiveness across the Data Management organization. This role works horizontally across Database Design, Data Acquisition, Medical Data Review, Analytics & Reporting, and Data Delivery functions to optimize end-to-end clinical data processes from protocol development through database lock and submission readiness.

The role serves as a key process leader responsible for identifying improvement opportunities, implementing scalable solutions, enhancing cross-functional integration, and ensuring consistent adoption of best practices across the Data Management ecosystem. The incumbent is expected to possess a strong understanding of the clinical data lifecycle, data flows, systems, and stakeholder interactions required to support high-quality and efficient clinical trial execution

Roles & Responsibilities:

• Lead process improvement initiatives across Clinical Data Management.
• Develop and maintain standardized business processes, workflows, templates, and operating procedures.
• Identify process bottlenecks, inefficiencies, and risks and implement sustainable solutions.
• Support adoption of Quality-by-Design (QbD) and Risk-Based principles.
• Act as a process liaison across DM sub-functions to ensure seamless end-to-end data flow.
• Facilitate alignment of workflows and handoffs across functions and systems.
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, and Technology teams.
• Support inspection readiness and compliance activities through process governance and oversight.
• Partner with digital and technology teams to optimize workflows and user experience.
• Promote adoption of innovative tools and technologies that improve efficiency, quality, and scalability.
• Support change management activities associated with process transformations.
• Develop training materials, job aids, and best practices.
• Mentor teams on process excellence methodologies and operational best practices.

Basic Qualifications and Experience:

• Bachelor's or Master’s Degree and 13+ years of Clinical Research, Clinical Data Management, Process Excellence, Quality Management, Analytics, Technology Enablement, or related industry experience

Preferred Experience:

• Experience across multiple Clinical Data Management functions, including Database Design, Data Acquisition, Data Review, Analytics & Reporting, or Data Delivery.
• Demonstrated experience driving process improvement, operational excellence, or business transformation initiatives.
• Strong understanding of end-to-end clinical trial data flow from protocol development through database lock and submission.
• Experience developing SOPs, governance frameworks, KPIs, and operational dashboards.
• Knowledge of CDISC standards, GCP, Quality-by-Design (QbD), Critical-to-Quality (CtQ), and Risk-Based Data Management principles.
• Experience leading cross-functional initiatives within matrix organizations.
• Green Belt, Lean, Six Sigma, Project Management, or Process Excellence certifications preferred.

Functional Competencies:

• Strong understanding of end-to-end clinical data lifecycle and data flow.
• Knowledge of Database Design, Medical Data Review, Data Acquisition, and Analytics processes.
• Process mapping, process optimization, and workflow design expertise.
• Clinical trial systems knowledge (EDC, CTMS, eTMF, Data Review and Reporting platforms).
• Quality Management Systems and inspection readiness practices.
• Change management and process adoption methodologies.
• Clinical trial governance and risk management principles.

Must-Have Competencies:

• Clinical Data Management experience across multiple sub-functions.
• Strong understanding of protocol-to-database-to-submission data flow.
• Experience leading cross-functional process improvement initiatives.
• Knowledge of GCP, clinical trial regulations, and data standards.
• Experience with process governance, SOP development, and compliance frameworks.
• Ability to analyze complex operational challenges and implement practical solutions.
• Strong stakeholder management across matrix organizations.

Soft Skills:

• Strategic and systems thinking.
• Influencing without authority.
• Excellent verbal and written communication.
• Strong facilitation and presentation skills.
• Collaboration and relationship building.
• Continuous improvement mindset.
• Problem-solving and analytical thinking.
• Leadership, coaching, and mentoring capabilities.
• Adaptability and change agility.
• Strong business acumen and decision-making skills.

EQUAL OPPORTUNITY STATEMENT

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.

We will ensure that individuals with disabilities are provided with 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.

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