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Clinical Data Manager 8/30/2016

RTI International Rtp, NC

Company
RTI International
Job Classification
Full Time
Company Ref #
17462
AJE Ref #
576014146
Location
Rtp, NC
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Job Description

Job Title:

Clinical Data Manager

Job ID:

17462

Location:

RTP, NC

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Job Description

RTI International s Clinical Research Informatics Program is seeking a Clinical Data Manager to assist with the collection, management, and processing of data for a variety of multi-site research networks. The clinical data manager will work collaboratively as part of a multidisciplinary team to develop, test and manage research data and systems using a variety of off-the-shelf products and in-house software applications. Responsibilities include supporting the lead data manager and/or performing all data management activities on one or more clinical trial projects, monitoring and liaising with the clinical sites as required and keeping the team informed of study issues and progress.



Responsibilities

* Assist with designing CRFs and eCRFs for data acquisition and data entry

* Assist with developing test cases and performing user acceptance testing of EDC systems

* Assist with developing training materials, project documentation, GCP materials

* Performing QC review of the data and coordinating timely corrections to the database with the clinical sites

* Assist with monitoring study metrics and site performance using standard study management tools

* Assist with establishing data and work flow plans

* Contributing to the development and implementation of SOPs, project-specific procedures, and technical guidance documents



Qualifications

Education and Experience:

* Bachelor's degree

* 1-3 years of related professional experience

* A combination of performance, education and prior work experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily

Required:

* Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require

* Strong IT skills, including excellent knowledge of various software programs and packages including MS PowerPoint, MS Word, Excel

* Ability to work effectively both as part of a project team and independently is essential

* Excellent oral and written communication skills in English

* To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status



Preferred:

* Experience using Medidata RAVE or other electronic data capture system

* Experience providing project and data management support on FDA regulated studies, complex multi-site studies or data coordinating center projects

* Experience using data management systems, tools and processes to support multi-site, multi-mode research studies

* Ability to effectively apply knowledge and skills in an organized fashion while adhering to required guidelines, SOPs and client expectations

* Good organizational skills with strong attention to detail

* Ability to work productively with minimal supervision

* Strong customer focus and excellent interpersonal skills

* Ability to meet timelines or be able to recognize and schedule changes in response to project demands



#LI-KV1





About RTI

RTI International is one of the world's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our staff of more than 4000 provides research and technical services to governments and businesses in more than 75 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy and the environment, and laboratory testing and chemical analysis.



Equal Opportunity Employer

We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.



Closing Statement

RTI participates in the US Government E-Verify program. Further information regarding the E-Verify program and laws that are designed to protect you against discrimination relating to your legal right to work in the US can be found at www.rti.org/jobs



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