Late Phase Clinical Research Manager
On-siteAustin, Texas, United States
Job Summary
Manage all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Serve as the primary point of contact for the project team and business unit regarding clinical site aspects, collaborating with internal departments to ensure deliverables meet contract and timeline definitions. Oversee clinical and administrative functions including site setup, recruitment, conduction, and data collection, while handling IRB submissions, informed consent forms, and SAE notifications. Collect cross-departmental feedback to maintain the risk register and finalize the risk mitigation plan with the Principal Investigator. Manage fiscal aspects of study conduct, adhere to protocol and SOPs, and provide vendor oversight for contracted services.
Required Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Knowledge of Phase I processes
- Strong knowledge of clinical study operations
- Knowledge of FDA regulations
- Knowledge of ICH GCP guidelines
- Solid computer skills with working knowledge of Microsoft Office applications
- Good time management and multi-tasking skills
- Solid written and verbal communication skills
- Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
- Favorable consulting skills with the ability to act as a liaison between external and internal groups
- Knowledge of budgeting/forecasting/planning projects
- Exposure to biological fluids with potential exposure to infectious organisms
- Exposure to electrical office equipment
- Personal protective equipment required such as protective eyewear, garments and gloves
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