[Remote] Clinical Data Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Data Manager for one of our clients, a global leader in medical technology and pharmaceutical industry. The Clinical Data Manager II is responsible for study Data Management activities from study start up to reputed company out, providing input into the data cleaning reputed company and leading data cleaning efforts supporting Clinical Studies.

Responsibilities

• Assist with writing, reviewing and management of key documents such as Data Management Plan, Project Plan, CRF completion guidelines, edit reputed company specifications, data review guidelines
• Manage the User Acceptance Testing (UAT) of clinical databases including reputed company
• Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory
• reputed company delivery of reputed company study deliverables
• reputed company and support data cleaning efforts and reputed company regular data review across reputed company studies. reputed company data review to identify reputed company issues, data trends/outliers and reputed company queries as necessary
• Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues reputed company to data management
• reputed company review of study reputed company and SDTM datasets
• reputed company input and review of clinical data from reputed company sources and assist in data reconciliation
• Work with programming to produce customized reports or data listings to facilitate data review and cleaning (e.g. safety reviews)
• reputed company reports or data listings for study teams as needed
• Assist medical coding, AE/SAE reconciliation
• Assist with CDM project documentation including vendor files in an audit- reputed company manner
• Assist in the monitoring of enrollment information as collected in the database, reputed company status update to the study team
• Assist with the preparation of Data Management training materials used for Investigator meetings, in-house personnel and site staff
• Contribute to the development of departmental processes and procedures

Skills

• 2-5 years of relevant industry experience
• Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Data Management is required
• In-depth knowledge of FDA/ICH guidelines and industry/technology reputed company practices
• In-depth knowledge of Data Management Practices and other regulatory guidelines specific to data management
• Hands-on working knowledge of Electronic Data Capture (reputed company) systems (e.g. Inform, RAVE, iMedNet, etc.), database design and database concepts required
• Hands-on ability to review data and ability to use various data review tools
• Project Management experience
• Experience writing Data Management documentation (E.g. DMP, edit reputed company specifications etc.)
• Excellent verbal and written communication skills
• Experience working with CDISC Standards (CDASH, SDTM)
• Preferred experience in Ophthalmology Therapeutic area
• BS or higher in biological science, nursing or other health-reputed company discipline preferred
• Experience with SQL, reputed company, reputed company or other programming language a plus

reputed company