Senior Clinical Study Manager
HybridSunnyvale, California, United States
Job Summary
Lead US and global first-human-use and pivotal pre-market clinical trials to drive regulatory approvals and strategic evidence initiatives. Design and develop clinical protocols, study documents, and IRB/EC submissions while managing site selection, start-up, enrollment, and follow-up. Oversee CROs and third parties, conduct site qualification and monitoring visits, and ensure regulatory and protocol compliance. Collaborate with investigators, KOLs, biostatisticians, and cross-functional teams to analyze data, develop clinical study reports, and support scientific publications. Mentor junior managers and guide CRAs/CTAs on monitoring needs. Manage site payments, negotiate contracts, and prepare manuscripts for scientific meetings.
Required Qualifications
- extensive experience with planning, study start-up, and execution of clinical studies
- experience previously managing premarket studies in the United States and/or experience with multi-national studies
- experience scoping research topics to provide recommendations on clinical trial strategy
- experience identifying, reviewing, interpreting and summarizing clinical literature
- Previous experience managing and implementing pre-market medical device trials
- Significant knowledge of clinical and/or outcomes research study design
- Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
- Proven experience in conducting literature searches, reviews and appraisal of the scientific data
- Excellent ability to interact with physicians and other professionals inside and outside the company
- Knowledge of Good Clinical Practice ICH/GCP, FDA regulations, and other applicable regulations
- fundamental knowledge of clinical research and monitoring requirements
- Experience negotiating clinical research contracts and budgets
- Must be able to work effectively on cross-functional teams
- Must be able to travel 25-40% or based on business requirements
- Must be able to manage multiple projects and/or manage different priorities
- Proven communication, presentation and relational skills with high attention to detail and organization
- Ability to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties
- Ability to drive project team consisting of CRAs and CTAs
- Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset
- Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in industry sponsored clinical research
- Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in industry sponsored clinical research
- minimum of 10 years of experience in industry sponsored clinical research with relevant training
Desired Qualifications
- experience previously managing premarket studies in the United States and/or experience with multi-national studies
- experience scoping research topics to provide recommendations on clinical trial strategy
- experience identifying, reviewing, interpreting and summarizing clinical literature
- Accustomed to working in a hospital environment, experience working with nurses and physicians preferred
- Knowledge of statistics, statistical methods, and design of experiment is highly preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.