Director, Clinical Affairs
at HealthCare Recruiters International

Date Posted: 1/10/2019

Job Description

Overview of Position Reporting to the VP of RA/CA/QA, this person will oversee all aspects of the company's clinical trials. This is a full-time position based in Santa Rosa, though working from home is possible for part of work week Duties Responsibilities

• Oversee design, execution and monitoring of the company's clinical trials

• Responsible for creation and maintenance of all study related documents

• Clinical representative and decision maker on cross functional project team for development of next generation devices

• Interact effectively with the regulatory lead in regulatory submission strategies

• Hire and manage CROs as necessary

• Hire and manage any required in-house clinical staff

• Become in-house expert for all the company's clinical data

• Act as clinical reviewer on all regulatory submissions and internal documents such as DCRs, etc.

• Interact with KOLs as needed Minimum Education Requirements

• BA/BS in life science, required

• MS, preferred Minimum Experience Requirements

• Minimum of 10 years relevant experience in clinical roles including research, study design, protocol writing and implementation/management of trials, registries and other relevant activities

• Experience in the design, implementation and completion of at least 1 major clinical study, registry or trial

Job Snapshot

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