Data Manager/Sr. Data Manager
Location: Little Falls New Jersey
Description: Clinical Solutions Group is presently looking of Data Manager/Sr. Data Manager right now, this vacancy will be placed in New Jersey. For detail informations about this vacancy opportunity please give attention to these descriptions. Growing International CRO with stateside office in Northern NJ has an immediate need for a perm based Data Manager or Sr. Data Manager. Company President is looking to hire just 1 person and is flexible on level. Relo available for right out of town prospect, but local candidates are preferred.
DATA MANAGER
The Clinical Data Manager will lead assigned data management projects by applying project management skills and data management techniques to ensure timely and quality deliverables to our clients. The in! cumbent will manage project timelines and coordinate activitie! s for assigned projects, and be responsible for the development of Data Management Plans, clinical trial case report forms, databases, and overseeing data processing and performing database quality control procedures.
A bachelors' degree in health science, registered nurse, or higher equivalent education in relevant disciplines, with a minimum of 3 years experience in clinical trial data management, and demonstrated leadership ability to effectively manage clinical trial data management activities and integrate them with the entire clinical trial operations; must communicate effectively, orally and in writing. Experience with clinical trial electronic data capture systems and in particular must have experience using MediData Rave. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required. In addition, the incumbent must have excellent oral and written communication skills and to apply su! ch skills in logical and algebraic operations. Salary is commensurate with experience.
SENIOR CLINICAL DATA MANAGER
The Senior Clinical Data Manger is the key contact person for data management activities for multiple pharmaceutical sponsor companies. The incumbent will be accountable for performing data processing and management activities for assigned projects.This will involve such activities as: design and review patient Case Report Forms and database schema;test data capture/entry screens;review CRFs and generate data query reports; follow up with study sites to resolve queries; assist in resolving data coding discrepancies; perform quality control audits on assigned databases during the trial and additional database closure checks at the end of the study; validate and disseminate real-time study monitoring reports to study team members; perform coding for Adverse Events using MedDRA; lead efforts in developing and maintaining standard database integrity c! hecks. In addition the incumbent will be responsible for training on da! ta management processes and procedures with new data management personnel.
A bachelors' degree in health science, physical or biological fields with at least 7 years experience in clinical trial data processing and management. Education and experience must demonstrate leadership ability and the ability to effectively work independently. The incumbent must have a proven track record in managing clinical trial data management activities, applying data management concepts, clinical trial data processing techniques, and integrating them with the entire clinical trial operations. Experience with clinical trial electronic data capture systems and in particular must have experience using MediData Rave. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required.In addition, the incumbent must have excellent oral and written communication skills and to apply such skills in logical and algebraic op! erations.
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Clinical Solutions Group.
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This vacancy starts available on: Tue, 10 Dec 2013 07:22:32 GMT