Operations Manager, Digital Medicine
The Operations Manager, Digital Medicine supports the study-level design and leads execution of digital medicine studies, including digital components and integrating pragmatic and decentralized approaches into clinical trials.
This role partners closely with study teams and Senior Managers to translate Digital Medicine strategy into fit‑for‑purpose study designs and operational plans. The Operations Manager ensures that digital health technologies and decentralized methodologies are effectively embedded within protocols and executed with operational excellence.
The role represents a key bridge between strategy and delivery, with accountability for both study-level design input and execution.
Key Responsibilities
- Contribute to study design by integrating pragmatic and decentralized elements aligned with clinical and product strategy
- Translate digital medicine strategy into actionable study-level plans, including selection of endpoints, technologies, and operational approaches
- Provide input on protocol design, feasibility, and patient‑centric approaches enabled by digital solutions
- Ensure alignment between digital design elements and study objectives, endpoints, and regulatory considerations
- Ensure successful implementation of decentralized trial elements (e.g., ePRO, wearables, remote monitoring, hybrid/virtual visits)
- Manage timelines, deliverables, and performance of digital/decentralized components across the study lifecycle
- Serve as the study-level lead for digital medicine activities
- Partner with clinical study teams to embed and operationalize digital strategies
- Act as a key contributor in study planning discussions, bringing digital and DCT expertise
- Lead evaluation, selection, and oversight of digital health technologies and vendors
- Ensure vendor solutions align with protocol requirements and patient experience considerations
- Manage vendor performance, issue resolution, and delivery of milestones
- Collaborate with clinical operations, medical, regulatory, safety, and other functions
- Ensure digital components are fully integrated into broader study plans
- Stay current on evolving decentralized trial methodologies and digital health technologies
- Translate external trends into practical applications for study design and execution
- Support adoption of innovative approaches within study teams
- Communicate study design considerations, risks, and execution updates clearly
- Develop materials to support study teams and leadership discussions
- Influence stakeholders on adoption of pragmatic and digital approaches at the study level
What We Expect Of You
Basic Qualifications:
- Degree educated with 5+ years of relevant clinical study management experience
Preferred Experience:
- Minimum of 5 years of experience in clinical development, digital health, or related field, including leadership in DCTs and pragmatic trials. Preferably in cardiovascular, rare diseases, oncology and inflammation.
- Understanding of clinical trial operations, regulatory requirements, and digital health technologies.
- Experience implementing digital strategies (ePRO, wearables, digital tools, etc.) in clinical research at a global or regional level.
- Strong communication and stakeholder management skills; ability to influence across levels and functions.
- Post‑Marketing / Phase 4 experience.
- Experience of fully outsourced studies.
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 a 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 an accommodation.
#J-18808-Ljbffr