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14 days old

Clinical Data Manager (Clinical Trials) - NIH

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 Clinical Data Manager at the National Institutes of Health in Rockville, MD.


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) Act as subject matter expert (SME) for all data management activities including proper data entry and tracking, human subjects protection, data confidentiality and related IT security.

(2) Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by the Division of Allergy, Immunology, and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), and/or additional relevant clinical data databases including those of DAITs clinical research organization (CRO) awardees.

(3) Provide expertise to sponsor clinical data management projects on multiple complex studies and programs, both internal and performed by supporting clinical research organizations (CROs).

(4) Provide technical oversight of CROs performing core data management functions including case report form (CRF)/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.

(5) Provide expertise to assist in CRF and database design.

(6) Perform or oversee development of clinical data management validation plans, data transfer requirements and agreements, and data management plans.

(7) Devise and oversee implementation of quality assessment procedures according to data management plans and other means.

(8) Assist with the creation and review of CAPAs related to clinical data management.

(9) Review and process clinical trial data to ensure data quality for data analysis.

(10) Provide input on clinical data management system enhancements including design, review, performing user acceptance testing and validation supporting activities.


REQUIREMENTS. The contractor must have:

(1) Masters degree in a related discipline; Ph.D. in a related discipline a plus.

(2) Minimum of five (5) years of clinical data management experience

(3) Knowledge of clinical data management tools, experience developing eCRFs and clinical databases, and experience creating and evaluating SOPs and CAPAs

(4) Experience creating and evaluating clinical data management plans and agreements

(5) Familiarity with clinical trial data standards such as CDISC preferred

(6) Experience programming and using Medidata Rave, Oracle Argus and RedCap preferred

(7) Excellent computer skills that ideally includes proficiency in Microsoft Office, SQL, XML, and statistical software such as R, SAS, Stata, & SPSS

(8) Thorough understanding and experience with GCP/GxP, Privacy Act and quality requirements

(9) Pharmaceutical industry experience a plus


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.


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.


\#ACRP


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-10 Expires: 2021-10-16

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Clinical Data Manager (Clinical Trials) - NIH

Kelly Services
Rockville, MD 20851

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