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14 days old

Clinical Trials Data Manager - NIH - Bethesda, 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 individual to work as a Clinical Trials Data Manager at the National Institutes of Health in Bethesda, 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 10 paid federal holidays and 401K plan.

+ Access to NIHs unparalleled resources and niche scientific initiatives


TASKS/SERVICES. The contractor shall:


+ 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.

+ Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by DAIT and/or NIAID and additional relevant clinical data databases including those of DAITs clinical research organization (CRO) awardees, ImmPORT and ClinicalTrials.gov .

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

+ 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.

+ Responsible for the oversight of clinical data management study deliverables, evaluating and mitigating data management risks.

+ Provide expertise to assist in CRF and database design.

+ Assist in the development and implementation of data transfer and migration plans relating to transitions between CROs.

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

+ Provide expertise in support of developing sponsor data management SOPs, procedures, PWIs, Plans, Guidance and other quality-related documentation.

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

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

+ Assist with the creation and review of CAPAs related to clinical data management.

+ Review and process clinical trial data to ensure data quality for data analysis.

+ Participate in clinical study data reviews and other activities related to database lock.

+ Participate in multi-party clinical data process development initiatives.

+ Assist in the development of data pathways and system interconnection arrangements.

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


REQUIREMENTS. The contractor must have:


+ Masters degree in a related discipline required. A Ph.D. in a related discipline a plus.

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

+ Excellent verbal and strong written communication skills are required as this person is expected to interact with team members from various disciplines every day.

+ Excellent analytical, organizational and time management skills required.

+ Thorough understanding and experience with GCP/GxP, Privacy Act and quality requirements are required.

+ A working knowledge of clinical data management tools is required.

+ Experience programming and using Medidata Rave, Oracle Argus and RedCap preferred.

+ Familiarity with clinical trial data standards such as CDISC preferred.

+ Experience in developing eCRFs and clinical databases required.

+ Experience creating and evaluating clinical data management plans and agreements preferred.

+ Experience working within a quality-driven environment is preferred.

+ Experience creating and evaluating SOPs and CAPAs required.

+ Systems validation experience preferred.

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

+ Pharmaceutical industry experience a plus.

+ Excellent computer skills, proficient in Microsoft Office, SQL and XML required.

+ Experience with statistical software such as R, SAS, Stata, & SPS preferred.


**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.


**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: 2021-04-28 Expires: 2021-05-31

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Clinical Trials Data Manager - NIH - Bethesda, MD

Kelly Services
Rockville, MD 20851

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