Clinical Data Manager
Trident Consulting•Aliso Viejo, CA
•$49•Remote
About The Position
Trident Consulting is seeking a Clinical Data Manager for one of our clients in Aliso Viejo, CA - Remote. This global leader in the medical technology and pharmaceutical industry is looking for a Clinical Data Manager II responsible for study Data Management activities from study start up to close out. The role involves providing input into the data cleaning strategy and leading data cleaning efforts supporting Clinical Studies. This individual must possess strong project management and analytical skills and have the ability to review data using various reporting and analytics tools.
Requirements
- 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 standard practices
- In-depth knowledge of Data Management Practices and other regulatory guidelines specific to data management
- Hands-on working knowledge of Electronic Data Capture (EDC) 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 check specifications etc.)
- Excellent verbal and written communication skills
- Experience working with CDISC Standards (CDASH, SDTM)
Nice To Haves
- Preferred experience in Ophthalmology Therapeutic area.
- Experience with SQL, SAS, Excel or other programming language a plus
- BS or higher in biological science, nursing or other health-related discipline preferred
Responsibilities
- Assist with writing, reviewing and management of key documents such as Data Management Plan, Project Plan, CRF completion guidelines, edit check specifications, data review guidelines.
- Manage the User Acceptance Testing (UAT) of clinical databases including EDC.
- Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory.
- Oversee delivery of EDC study deliverables.
- Oversee and support data cleaning efforts and perform regular data review across Glaukos studies.
- Perform data review to identify quality issues, data trends/outliers and generate queries as necessary.
- Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management.
- Perform review of study SAS and SDTM datasets.
- Provide input and review of clinical data from external 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).
- Generate 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- ready manner.
- Assist in the monitoring of enrollment information as collected in the database, provide 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
