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19 days old

Data Compliance Specialist (Interventional Clinical Trials) - 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 the leading medical research center in the world. We are seeking an experienced individual to work as a **Data Compliance Specialist** **(Interventional Clinical Trials)** at the National Institutes of Health in **Rockville, Maryland** .


**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 10 paid federal holidays and 401K plan.

+ Access to NIHs unparalleled resources and niche scientific initiatives


**TASKS/SERVICES. The contractor shall:**


+ Oversee Division of AIDS (DAIDS) sponsor Clinical Data Management activities and project timelines on


multiple complex interventional clinical trials networks operating in a global setting.


+ Oversee technical service providers performing core data management functions including but


not limited to CRF/edit check development, user acceptance testing, data cleaning, listings


review, data freeze, and database lock procedures.


+ Responsible for the oversight of clinical data management deliverables.

+ Evaluate and mitigate clinical data management-related risks across programs on behalf of the


Division of AIDS.


+ Conduct 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.


+ Apply expert knowledge of regulations governing interventional clinical trials data collection,


processing, and systems as evidenced by: proficiency in CFR 21 Part 11, GAMP5, ICH E6 R2,


+ ISO, and any additional regulatory requirements and guidance for data management and


electronic information systems for clinical trials, CDISC requirements, ICH Good Clinical


+ Practice (GCP), and Good Clinical Data Management Practices (GCDMP) into routine oversight


functions.


+ Utilize expert technical knowledge and experience in developing and overseeing systems development approaches and systems integrations for complex global interventional clinical


trials data management requirements.


+ Lead and participate in cross-functional data management-related process initiatives or


working groups on behalf of the Division of AIDS.


+ Perform project management of multiple ongoing data management activities.

+ Responsible for overseeing the end-to-end clinical data management-related activities and is the


ultimate accountable person for the data management deliverables in terms of quality and delivery according to plan.


+ Provide technical leadership for and oversight of clinical data management activities, including:


1. implementation of data management aspects of clinical protocols and data collection


systems;


1. strategic input into proposal or protocol design focused on data management considerations;

2. mitigation of potential data management issues by reviewing protocols or other documents


for cross-project consistency and identifying standard case report form modules to meet


objectives;


1. reviewing data management activities and recommending process improvements; and,


maintaining high-level oversight on data quality metrics and data management deliverables.


**REQUIREMENTS. The contractor must have:**


+ Masters degree in a related field is required

+ Minimum of 15 years of relevant experience

+ Demonstrated experience with interventional clinical trials data collection, processing, and systems as evidenced by: proficiency in CFR 21 Part 11, GAMP5, ICH E6 R2, ISO

+ Knowledge of regulatory requirements and guidance for data management and electronic information systems for clinical trials, CDISC requirements, ICH Good Clinical Practice (GCP), and Good Clinical Data Management Practices (GCDMP) into routine oversight functions.


**PLEASE APPLY ONLINE**

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; a full job description can be made available at that time.


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.


You should know: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.


**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.


**You should know:** Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.


**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)

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Posted: 2021-11-08 Expires: 2021-12-09

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Data Compliance Specialist (Interventional Clinical Trials) - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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