Clinical Data Manager

Katalyst Healthcares & Life Sciences • Cambridge, MA

210d

About The Position

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Requirements

• Clinical Database Systems Knowledge - EDC and Paper
• Intermediate to Advanced level proficiency with relational databases
• Big-picture and detail-oriented view of data management processes
• Knowledge of coding process and coding tools
• Bachelor's Degree and a minimum of 3-5 years related experience in a medical device and/or pharmaceutical data management environment
• Computer proficiency in MS Word, Excel, PowerPoint, Access, ORACLE Clinical, Clindex, CRF design tools
• Proficient Data management skills on various types of clinical trials
• Experience with reporting tools (e.g. TOAD, Discoverer, Crystal Reports, Clindex Reports)
• Excellent organizational skills and attention to detail
• Minimal travel may be required (10-20%)

Responsibilities

• Design of Case Report Forms (CRF)
• Development of edit check specifications
• Creation of test scripts and testing of study database
• Query processing and data reporting
• Putting in place data management plans and timelines
• Manage multiple projects through closeout and archiving
• Assist/lead with study start-up activities like training sites and internal users
• Attend clinical project meetings
• Perform data management activities on both Electronic Data Capture (EDC) and paper studies
• Act as lead data manager for projects and/or programs
• Collaborate with CRAs or Clinical Project/Program Managers for CRF design and development
• Work closely with clinical project team and database programmers
• Ensure study data quality by CRF data review and query processing
• Create and maintain essential data management documentation
• Perform user acceptance testing and database quality control
• Collaborate with CDMs and other staff as necessary
• Act as a point of contact with vendors
• Assist in overall project tasks such as process flowcharts and SOPs
• Participate in project meetings to give status updates
• Collaborate with Medical coder for clinical reporting
• Ensure good Clinical Data Management practices
• Seek out adequate training on products and therapeutic areas
• Contribute to review of draft/final tables and clinical study reports
• Oversee major data management activities
• Ensure coding reviews/discrepancy actions are applied
• Prepare study material for investigator and monitor meetings
• Comply with written procedures, instructions, SOPs, and other documents

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree