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24 days old

Senior Analyst, Clinical Research

Kelly Services
Fremont, CA 94536
Kelly has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary position with a new client that is seeking a **Senior Analyst, Clinical Research in Fremont, CA** . If interested/available, please reach out to me directly at bryh262@kellyservices.com.


Pay Rate: Negotiable


Shift: Monday Friday, 1 st shift


Duration: End of year with possible extension


Location: 100% remote


**This role will be 100% remote. A client issued laptop will be shipped to the persons home office for their use** .



**Job Summary:**

You will be responsible for the execution and implementation of a large data migration for a medical device clinical trial. The scope of this project includes transferring study documents stored in SharePoint electronic training master file (eTMF) and filing them appropriately in Medidata eTMF.


**Job Description:**


+ Senior Analyst, Clinical Research will ensure essential document readiness for the planned data migration of study and site files onto Medidata eTMF.

+ Transfer data from SharePoint (file based electronic storage into the Medidata platform.

+ QC of regulatory documents, audit files for missing documents, work with CRAs to complete corrections and obtain missing documents from sites.

+ Work with the Project Team help verify the accuracy and completeness of the data transfer from SharePoint into the Medidata platform

+ Provide Medidata support to study team

+ Support active studies with document readiness for migration onto Medidata eTMF

+ Must be a self-starter

+ Must be an excellent verbal and written communicator

+ Must effectively communicate progress and challenges to the study lead.


**Education:**


+ Bachelor's degree in health/science field

+ 3+ years experience working for Industry-Sponsored clinical trials is required

+ Experience reviewing regulatory documents for clinical trials required

+ Experience navigating DIA eTMF placeholder map required

+ Medidata experience and knowledge required

+ MS SharePoint experience and knowledge required

+ Good Documentation Practices (GDP) proficient required

+ GCP understanding required

+ Strong communication skills required


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-01 Expires: 2021-11-01

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Senior Analyst, Clinical Research

Kelly Services
Fremont, CA 94536

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