28 days old

Senior Clinical Data Manager - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851
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

TASKS: The contractor shall:

+ 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: The contractor must have:

+ Masters degree in a related discipline; three (3) years of specialized experience plus a Bachelors degree is equivalent to a Masters degree.

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

+ At least five (5) years of clinical data management experience is required.

+ Working knowledge of clinical data management tools.

+ Experience programming and using Medidata Rave desired.

+ Systems validation expertise and/or experience.

+ Knowledge of data systems architecture and structure of data systems.

+ Pharmaceutical industry experience a plus.

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

+ Excellent analytical, organizational and time management skills.


Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.

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

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.

**About Kelly** ****

Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.

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. (


Posted: 2021-01-27 Expires: 2021-03-04

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Senior Clinical Data Manager - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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