Senior Clinical Data Manager - NIH - Rockville, MD

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers.  Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world.  We are currently seeking a Senior Clinical Data Manager, with demonstrated experience in clinical trials, to work onsite with the National Institutes of Health in Rockville, MD.

This is a long-term contract position which offers:

 - Competitive salary with comprehensive benefit package

 - Opportunity to work at NIH, the world's foremost medical research center

 - Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com

TASKS

  • Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs.

  • Provide technical oversight of service providers performing core data management functions including CRF/ edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.

  • Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs.

  • Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing.

  • Conducts data reviews.

  • Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards.

  • Provide input on the clinical data management system enhancements including performing UAT (User Acceptance Testing)

  • Participate in cross-functional process initiatives.

  • Perform clinical data management activities including developing of Data Transfer requirements and DMP (Data Management Plan), reviewing and processing clinical trial data to ensure data quality for data analysis and database lock.

  • Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by NIAID (National Institute of Allergy & Infectious Diseases), or as necessary, clinical study related information from databases used by other Branches or Offices in NIAID.


REQUIREMENTS:

  • Master’s degree in a related discipline; three (3) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.

  • Minimum of three (3) years of related clinical data experience.

  • Working knowledge of clinical data management tools.

  • Experience programming and using Medidata Rave.

  • Systems validation expertise and/or experience.

  • Pharmaceutical industry experience a plus.

  • Expertise in Microsoft Office Suite (MS Word, Excel, Outlook).

  • Excellent analytical, organizational and time management skills.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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