Resource Allocation & Program Engagement
Partner with resourcing leads to assign associates based on skills, experience, and workload.
Monitor capacity and forecast demand; raise gaps early and propose rebalancing plans.
Ensure associates are prepared for study assignments (access, training, expectations, handoffs).
Track allocation health (over/under allocation) and adjust proactively.
Capability Development & Continuous Improvement
Identify recurring gaps in skills, process adherence, or tooling and drive targeted training plans.
Promote standard ways of working for associate execution (templates, checklists, playbooks).
Capture lessons learned and share across the support pool to reduce rework and variability.
Encourage practical improvements that increase throughput and quality, not extra documentation.
Stakeholder Collaboration
Serve as point of contact for escalations related to associate performance, responsiveness, and quality.
Build strong relationships with study and program stakeholders to align expectations and resolve friction quickly.
Ensure consistent communication between delivery roles and the support pool on priorities and deadlines.
Quality & Compliance
Ensure associates operate within SOPs, work instructions, and quality standards, and support audit/inspection readiness by ensuring evidence is complete, traceable, and stored appropriately.
Partner with QA/Process leads to implement corrective actions when issues recur.
Monitor basic quality indicators for support work (cycle time, error rates, rework, backlog).
Resource Management Support
Support the functional resourcing team as needed (hiring coordination, allocation tracking, forecasting inputs) and provide reporting on team capacity, utilization, and skill coverage to enable portfolio planning.
Basic Qualifications and Experience
Doctorate degree OR
Master’s degree and 2 years of clinical data management / clinical data operations experience OR
Bachelor’s degree and 4 years of clinical data management / clinical data operations experience OR
Associate’s degree and 8 years of clinical data management / clinical data operations experience OR
High school diploma / GED and 10 years of clinical data management / clinical data operations experience
Preferred Experience
5+ years in life sciences, with at least 3 years focused on clinical data management / clinical data operations supporting interventional trials.
Experience leading teams that execute high-volume clinical data management work (startup activities, data review/cleaning, reconciliation, issue management).
Experience supporting multiple studies and/or programs in parallel with shifting priorities.
Functional Competencies
Must-Have Competencies
Pharmaceutical Expertise: Understanding of clinical trial execution and how Data Management supports startup, conduct, and closeout. Prior experience in clinical data management, data operations, data capture, database build, and/or external data acquisition preferred.
Management Experience: Experience managing and developing a team (preferably remote and/or across time zones), including coaching, performance management, balancing, and delivering through competing priorities.
Tech Skills: Comfortable working in common clinical data platforms and workflows. Proficient in Excel; familiarity with basic data concepts (datasets, reconciliation logic, edit checks) and reporting/metrics expected.
Operational execution and prioritization: Balances capacity, timelines, and shifting priorities across studies without dropping critical work.
Quality mindset and inspection readiness: Drives right-first-time execution, documentation discipline, traceability, and consistent adherence to SOPs/WIs.
Process discipline: Establishes standard ways of working (templates, checklists, playbooks) and reduces variability across the support pool.
Stakeholder management: Communicates clearly with data delivery leads, program stakeholders, and resourcing partners; resolves conflicts quickly.
Data fluency: Understands core data management concepts (edit checks, discrepancies, reconciliation, external data flows) well enough to challenge and support the team.
Structured problem solving: Identifies recurring issues (backlogs, rework drivers, error patterns) and implements practical fixes.
Global collaboration: Sets expectations for responsiveness, handoffs, and asynchronous work across time zones.
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 an accommodation.
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