Sr. Clinical Data Manager in Bedminster Township, NJ at Apex Life Sciences

Date Posted: 5/27/2018

Job Snapshot

Job Description

Primary Job Responsibilities: 

• Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms 

• Review Protocols to ensure database feasibility 

• Develop/build, review, and maintain a clinical database and supporting specifications documentation 

• Develop/build, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing) 

• Develop data transfer agreements and specifications with various vendors 

• Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation 

• Perform all aspects of DM process as related to processing and QC of the data 

• Clean data for study close out and perform all database lock procedures 

• Manage reconciliation with any external data (e.g. SAE, lab) 

• Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team 

• Use standard conventions, tools, references and process in support of the coding of medical terms 

• Ensures all DM procedures executed with a high attention to detail, accuracy and timelines 

• Represent the DM function on project teams 

• Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing 

• Maintain CRFs m1d database standards 

• Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection 

• Mentor junior level staff on database management tasks and processes 

• Contribute/participate in data management initiatives 

• Other duties as assigned 

Computer Skills: 

• Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail 

• Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems 

• Experience with SAS (Base, Stats, Macro, etc.) 

• Experience with CDISC SDTM/CDASH 

• Experience with study database build (including edit check programming) 

• Experience in software development, software implementation, testing and validation 

Education and Experience Required: 

• B.S. in Mathematics/Statistics, Computer Science, Life Sciences or related field 

• Minimum 8 years of data management experience in the pharmaceutical or biotechnology industry 

• Highly organized and detail-oriented with effective planning with strong verbal and written communication skills 

• Flexibility mi1d agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues 

• Experience/knowledge of GCP and ICH guideline