Senior Clinical Project Manager
Abarca HealthSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical Devices, Clinical ResearchIndustries
Requirements
Candidates should possess a Bachelor’s degree in Biological Sciences or a related field, such as Biology, Chemistry, Biochemistry, Nursing, Biomedical, or Veterinary Sciences, along with a minimum of 3 years of experience in clinical or scientific research, nursing, or a comparable combination of education and experience. Basic knowledge of medical terminology is required, and familiarity with laws, regulations, standards, and guidance governing clinical studies is preferred. Strong computer skills, including experience with spreadsheets and word processing programs, are also necessary.
Responsibilities
The In-House Clinical Research Associate II will draft study-specific informed consent templates, assist with developing and maintaining project timelines, prepare routine operations reports, and support the study start-up process across multiple studies, including ICF review, budget negotiation, and assisting clinical sites with IRB submissions. They will also drive study amendment and closeout activities, motivate clinical sites to meet study endpoints, provide support to Project Management in establishing clinical trial management processes, collaborate with the Clinical Field team to improve site activation, distribute and track regulatory documentation, assist with the development and maintenance of clinical infrastructure, provide updates to management regarding site progress, participate in audits, adhere to the Company’s Quality Management System, and perform other work-related duties as assigned.
Skills
Clinical Study Management
Regulatory Documentation
IRB Submission
Study Protocols
Informed Consent Drafting
Project Coordination
Audit Preparation
SOP Development
Penumbra Inc
Develops medical devices for vascular conditions
About Penumbra Inc
Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.
Alameda, CaliforniaHeadquarters
2004Year Founded
$116.7KTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees