9 days old

Remote Clinical Data Manager - NIH

Kelly Services
Rockville, MD 20851 Work Remotely
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 the leading medical research center in the world. We are seeking an experienced individual to work as a Clinical Data Manager/Advisor at the National Institutes of Health in Rockville, MD. _Please note option of 100% remote working arrangement is available._

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Vacation leave as well as paid federal holidays and 401K plan.

- Access to NIHs unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall:

(1) Oversee sponsor Clinical Data Management activities for the adaptive platform trial, ACTIV-2 for COVID-19 studies.

(2) Work collaboratively across multiple cross functional groups including Clinical Trial Managers (CTMs), Biostatistics and Clinical Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines.

(3) Provide technical oversight of service providers performing core data management functions including CRF/edit check development, user acceptance testing (UAT), integrated response technology (IRT), biostatistics, data cleaning, listings review, and database lock procedures.

(4) Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates data management-related risks across functional areas of ACTIV-2 on behalf of the trial sponsor, Division of AIDS.

(5) Conduct reviews of oversight related data, operations-related trend analyses, and performs report reviews.

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

(7) Responsible for overseeing the end-to-end data management study related activities in terms of quality and delivery according to plan on a day to day basis.

(8) Provide oversight for data management activities including: Implementation of data management aspects of ACTIV-2 and data collection systems; Strategic input into mitigation of potential data management issues; Review data management activities and recommend process improvements; Maintain high-level oversight on data quality metrics and data management deliverables.

REQUIREMENTS. The contractor must have:

(1) Masters Degree in related field

(2) Minimum of ten (10) years of related experience including expertise/focus on clinical data management


When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you arent contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.

It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.


**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** ****

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. (


Posted: 2021-09-15 Expires: 2021-10-18

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Remote Clinical Data Manager - NIH

Kelly Services
Rockville, MD 20851

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