Director Clinical Research Operations
About The Position
POSITION SUMMARY: The Director of Clinical Research provides strategic leadership for clinical research operations within the assigned area, advancing long-term vision, program growth, and alignment with organizational and Ministry objectives. The role oversees the local portfolio of clinical research programs including clinical trials (Phase I-IV), investigator-initiated research, scientific grant-funded research ensuring high-quality study execution, regulatory excellence, and integration of research into clinical care. The Director leads high-performing research teams, drives quality and performance improvement initiatives, and collaborates with research administration, executive leadership, investigators, industry partners, regulatory bodies, and academic institutions to expand research capability and innovation. The Director also contributes to strategic portfolio development and financial planning to ensure sustainable, mission-aligned research growth. Additionally, the Director provides expert input on clinical trial budget development, directs local financial and capital planning for research operations, ensures effective oversight of study activation and operational performance, and delivers high-level reporting and communication to the CMO, Research Administration, executive committees, and governing bodies.
Requirements
- Bachelor’s degree in healthcare administration, public health, nursing, biological/life sciences, or related field
- 7+ years progressive experience in clinical research operations within a healthcare or academic medical center environment.
- 3+ years in formal leadership role overseeing research coordinators, managers, or operational teams.
- Experience supporting industry-sponsored or FDA-regulated research.
- Demonstrated experience standardizing multi-departmental operational workflows.
- Research-related certification (Association of Clinical Research Professionals / Certified Clinical Research Coordinator (ACRP/CCRC), Society of Clinical Research Associates / Certified Clinical Research Professional (SOCRA/CCRP), Certified Healthcare Research Compliance (CHRC), Certified in Healthcare Compliance (CHC), etc.) expected within l yr on the job.
- Excellent interpersonal and communication skills.
- Solid computer skills, including proficiency with Microsoft software.
- Strong analytical and problem-solving skills, with the ability to be detail oriented.
- Strong understanding of clinical trial activation processes, study lifecycle management, and enrollment operations.
- Demonstrated ability to develop and track operational KPIs and performance dashboards.
- Strong project management and change management capabilities.
- Excellent communication and leadership skills.
- Familiarity with research systems (such as Epic research functionality, Clinical Trial Management Systems (CTMS), Research Electronic Data Capture (REDCap), iRIS/Cayuse).
- Basic understanding of research funding mechanisms, billing regulations, Medicare coverage analysis, and compliance frameworks.
- Demonstrated experience leading cross-functional department initiatives.
- Knowledge of research data governance, HIPAA, 21 CFR Part 11, and regulatory frameworks applicable to clinical research.
- Proven ability to lead teams, manage change, and drive continuous improvement.
Nice To Haves
- Master’s degree in healthcare administration, public health, business administration, or related field.
- Oncology research experience strongly preferred.
- Experience supporting research site growth strategies.
- Research related applications / software experience.
- Lean or Six Sigma certification.
- Project Management Professional (PMP).
- Knowledge of clinical research operations, study data management, and electronic data capture (EDC) systems.
- General understanding of medical terminology Clinical Trial Management Systems (CTMS), Research Electronic Data Capture (REDcap), Participant Payment Solution, Cosmos, and/or other research software systems.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
5,001-10,000 employees
