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Clinical Research Manager (Publications, Evidence Dissemination

Company: Johnson & Johnson Services, Inc
Location: Irvine
Posted on: September 16, 2021

Job Description:

Insight Global is looking for a Clinical Research Manager to work for a large medical device company located in Irvine, CA. This person will be responsible for taking the clinical research process from start to finish. Starting from developing and delivering appropriate evidence moving all the way to supporting the new product development and life cycle management. They will be responsible for ensuring input and strong alignment from key stakeholders and business leaders in the EGS/EDS activities and deliverables. This person will be responsible for analyzing and interpreting data and draw conclusions, then presenting that to internal stakeholders on a regular basis. They will be the leading a team through their assigned projects and guide them through the clinical programs - partnering with internal departments such as Biostats & Data Management, Medical Affairs, HEMA, and R&D to ensure an on-time, in budget, and adhering to compliance and regulations delivery. This person will also be responsible for helping in publication planning and development and manage the Investigator Initiated Study publications tracking. Lastly they will help support the implementation of new clinical systems/processes. Overall, they will be working with physicians, helping with manuscript or idea for an abstract. They will be partnering with an abstract working with physician to see how an abstract is going. Putting together a cross functional team meetings and touching base with physicians on number of key aspects.

- Relevant industry certifications - CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV - not necessary

- Experience managing projects

How many projects at one time - several - 15-20 projects at one time - a few wont be active at one time - generating an abstract takes 2-3 months, making a post of abstract of that post longer, true publications - 1 year

- Medical device experience +++ - someone strong in science and publication savvy

Medical writing and systematic literature review experience
- 6+ years of experience within in a clinical management role leading clinical research - publication experience!!!!

- Bachelors degree in Biological Science or related discipline

- Experience working with cross functional teams - effectively communicated with others

- Experience taking a clinical research project from start to finish - from the clinical research and process (GCPs) to product development keeping in mind team dynamics, the related healthcare market environment, clinical trends, and global clinical trial regulations (abstract or manuscript)

- Strong history of delivering clinical programs on time, within budget, and within compliance to the regulations and SOPs

Keywords: Johnson & Johnson Services, Inc, Irvine , Clinical Research Manager (Publications, Evidence Dissemination, Other , Irvine, California

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