Clinical Affairs Scientist Jobs
By MDC Associates, Inc. At Beverly, MA, United States
Knowledge of applicable protocol requirements as provided in company training
Study sites and clinical study management
Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies
Bachelor's degree in a health care or other scientific discipline or educational equivalent
5-10 years’ experience in a clinical environment or medical devices industry, with specific experience in in vitro diagnostic devices
Knowledge of the European Commission Medical and In Vitro Diagnostic Device Regulations.
Clinical Affairs Scientist- Clinical Development
By Agilent Technologies At San Francisco, CA, United States
Manages and oversees the governance, for internal and external stakeholders (Agilent and external laboratory sties, respectively).
4+ years of experience of industry experience in the fields of diagnostic, medical device and/or pharmaceutical products.
Knowledge of clinical study design, biostatistics, and Good Clinical Practice.
Experience working with external partners and/or regulatory bodies including the FDA.
Knowledge in oncology, companion diagnostic development, pathology, immunohistochemistry and/or next generation sequencing preferred.
Responsibilities include but are not limited to:
Clinical Affairs Jobs
By ProKatchers LLC At West Sacramento, CA, United States

The Clinical Affairs Scientist I will support the Clinical Affairs team during Microbiology antimicrobial susceptibility testing (AST) clinical trials. The incumbent performs testing as defined ...

Senior Clinical Affairs Specialist (Remote - Usa)
By Bionano At United States
Support input from clinical studies to development teams for key requirements and sample management.
Effective communication, organization, and time management skills.
Summary, Primary Duties, Skills And Experience
Manage project portfolio across clinical sites in multiple clinical studies.
Manage the publication process for internal publications including writing text and gathering data/figures from other contributors.
Experience working with technical teams.
Manager Clinical Affairs Jobs
By Kelly At Portland, Oregon Metropolitan Area, United States
Advanced computer skills including spreadsheet generation, word processing, database management, PowerPoint, and other necessary applications.
Represent clinical trial management during clinical trial case reviews with physicians, clinic/hospital staff, and coordinators.
Ability to provide strategic input into the management of study procedures and staffing personnel.
Medical, dental, and vision benefits
Company-paid life insurance and disability benefits, and EAP
Manage multiple clinical trials/registries from initiation through completion.