Data Management Coordinator-SAS
- Location: Boston, MA
- Posted: Feb 15, 2019
Under the direction of the Data Coordinating Center (DCC) Director or Finance Manager (ID), the Data Management Coordinator is responsible for off-site study coordination and data management oversight of protocols positioned at international sites. The Data Management Coordinator will provide study coordination of specific protocols including implementing and monitoring quality control SOPs, conducting periodic quality assurance monitoring, work with investigators to develop and implement protocols at the international sites. The Data Management Coordinator will develop case report forms consistent with clinical protocols and investigator input, sets up SOPs for data collection sites to provide data capture, and performs quality assurance audits to validate data in preparation for analysis by biostatisticians. The Data Management Coordinator will work with Director, study coordinator(s) and investigator(s) on data management needs customized to each protocol.Essential Responsibilities/Duties:
Works with investigators and DCC director to develop appropriate case report forms (CRFs) to capture clinical and laboratory data from approved clinical protocols.
Translates CRF into TeleForm data capture forms, develops standard operating procedures for use at the site and at the DCC for data collection, quality assurance and control.
Maintain, organize and coordinate TIFF/PDF images of captured case report forms for TeleForm reading and verification.
Develop clinical research databases using SAS software. Works with statisticians and investigators in creating the appropriate databases/datasets from collected data for analyses.
Perform quality control/assurance per standard operating procedures for each protocol. Coordinate QA/QC with on-site staff and investigators.
Maintains routine progress reports on protocol milestones.
Train on, and follow, sponsors standard operating procedures (SOP) as applicable for participating studies.
Assists on-site study coordinators, statisticians and investigators in meeting data collection milestones and generation of specialized reports and databases. Assists DCC Director and Programmer in developing and providing end user training and support of developed customized applications for each clinical protocol.
Performs other duties as needed or as assigned.
Must adhere to all of BMCs RESPECT behavioral standards.
Masters degree in public health or related field (biostatistics, medical sociology, epidemiology).
Must have minimum of two (2) years experience with clinical research. An equivalent combination of education and experience, which provides proficiency in the areas of responsibility, may be substituted for the above education and experience requirements.
Experience with statistical analysis software (SAS), understanding of data management in clinical/biomedical research necessary.
Knowledge and Skills:
Understanding of clinical research components data collection issues, human subjects protection, quality assurance and control.
Familiarity with ICH Good Clinical Practices (GCP) consistent with registration clinical trials (FDA Guidance for Industry for Computerized Systems used in Clinical Trials (Title 21 CFR Part 11)) preferred.
Intermediate proficiency with Microsoft Office applications, use of file transfer protocols (FTP) preferred.
Basic to intermediate programming ability in SAS statistical software. Includes ability to create databases, merge, import/export datasets and run statistical analyses under the guidance of biostatistician and investigator.
Ability to learn and assimilate other related computer applications into data management practices.
Excellent organizational skills, including ability to multi-task, set priorities and meet timetables while managing several simultaneous projects.
Excellent oral and written communication skills.
Great interpersonal skills and flexibility to work in a collaborative environment.
- Part time