eCRF Forms & Study Designer Job in Audubon 19403, Pennsylvania US
eCRF Forms Study Designer
BioClinica, Inc. is currently seeking an experienced Forms Study Designer in our Audubon, PA office.
Responsibilities Qualifications:
The Forms Study Designer is primarily responsible for developing electronic data entry screens (eCRF’s) and data dictionaries based on trial specific requirements.
This includes:
• Developing eCRF’s, including protocol specific visit components.
• Developing and maintaining code lists, panels and export tables from annotated CRF’s, SAS Proc Contents files, internal standards, departmental standards and/or customer specific formats.
• Assisting with metadata analysis in determining the best implementation strategies within the operational database, which includes providing mapping documents for elements requiring secondary programming carried out by others. In many instances this may require mapping operational datasets to Study Data Tabulation Model (SDTM) datasets
• Developing blank and annotated case report forms (aCRFs) based on customer requirements, incorporating the elements of the study created during the study design process.
• Developing SDTM annotated CRF’s, as required
• Developing study specific workbooks
• Developing and formatting individual patient profiles according to customer requirements
A strong candidate will possess the following:
• Bachelor’s degree preferred
• Experience developing case report forms or other documents and databases for use in electronic data collection systems and d
emonstrated ability to read and interpret documents used to support the development of clinical trial databases
Additional skill sets include:
• Strong problem-solving and organizational skills
• High attention to detail
• Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames.
• Excellent oral and written communication skills
• Working knowledge of one or more of the following CDISC standards: CDASH, SDTM, ODM and define.xml
Benefits:
Employees of BioClinica, Inc. enjoy a comprehensive benefits package including medical, dental, and Rx benefits from date of hire; company sponsored life, LTD, STD, ADD; 401K; tuition reimbursement; flex spending accounts; and a generous vacation policy.
About Us:
BioClinica is a global clinical trials service organization, providing medical image management and eClinical services. This includes electronic data capture and clinical data management solutions to pharmaceutical, biotechnology and medical device companies and other organizations, such as contract research organizations (CROs) engaged in clinical trials.
Our eClinical services include a variety of customizable solutions that enhance pharmaceutical and biotech companies’ ability to process and store clinical data through the use of proprietary software and hosting services. BioClinica technology improves data quality and allows our sponsors to see the results of their clinical trials faster and more accurately than with conventional paper-based methods. We offer a comprehensive array of eClinical data solutions, including Full Service EDC a combination of electronic data capture, interactive voice response, reporting and data management solutions and are focused on making the process of collecting and analyzing data from clinical trials faster, easier and more reliable.
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