Senior Manager, Safety (Clinical) - 27859BR - EN in Fremont, CA at Stryker Corporation

Date Posted: 3/28/2018

Job Snapshot

Job Description

Who we want

A lover of their team. Sees their team as unique individuals each deserving respect, dignity, and growth.
A vision-maker. Repeatedly tells their team what they’re working for and why it’s important.
A compass. Has high moral and ethical standards always, not just when someone is looking.
A connector. Communicates often and openly, and creates a feeling of succeeding and failing together.
A victor. Dependably executes the plan after generating it; someone who refuses to throw in the towel, pass the buck, or throw someone else under the bus when something doesn’t get done.

What you will do

As Safety Manager, you will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

As safety expert and team leader, you will make sure our devices do not cause adverse patient effects. You will work directly with study investigators and regulatory agencies. You will use product knowledge and quick thinking to solve problems and let doctors and nurses know about proper product use. You will also develop a Safety team as unique individuals. Your role can be shortened to: (1) safeguarding patients and (2) advancing stroke science globally.

Your main job responsibilities are:
  • Lead and develop a team of three medical research associates and a clinical science program manager
  • Give medical guidance to internal project teams and functions, external study investigators, and regulatory agencies
  • Approve adverse event narratives for medical accuracy
  • Oversee Clinical Evaluation Reports and strategies
  • Provide medical monitoring to ensure patient safety and adequate coding and reporting of adverse events
  • Support Quality Assurance in medical device reporting, health risk assessments, and product performance criteria

Job Requirements

  • MD (preferred), PhD in biological or life sciences, or Master’s in Public Health
  • 3+ years clinical trial experience and 10+ years of progressively more responsible experience in clinical or healthcare related field
  • Medical device industry experience strongly preferred
  • Managing a team experience strongly preferred
  • Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of global clinical studies, as well as preparation of clinical documentation in support of regulatory submissions

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