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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives.
- Design and develop clinical protocols and execute clinical studies with minimal supervision.
- Work closely with clinical research associates, clinical trial assistants, and data management for the conduct and execution of studies.
- Drive the progress of the trial during site selection, site start-up and through enrollment and follow-up.
- Provide guidance to monitors about monitoring needs, and oversee compliance work on the study.
- Take a leadership role in external communication with investigators and study teams.
- Complete source data verification of clinical study data entered in EDC system or on case report form.
Requirements
What you’ll need- Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant training.
- Previous experience implementing, helping and managing 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 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 as applicable to clinical projects (“Self-starter attitude”)
Benefits
Comp & perks- Health insurance
- Flexible working hours
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchclinical protocol developmentoutcomes research study designsource data verificationregulatory submission writingliterature searchclinical trial managementmedical device trialsGood Clinical Practice (GCP)clinical research contracts negotiation
Soft Skills
leadershipcommunicationpresentation skillsattention to detailorganizationinterpersonal skillscross-functional teamworkself-starter attitudeability to manage multiple projectsadaptability
