Clinical Data Manager
- 1 Occam Rd, Guildford GU2 7YQ, UK
Founded in 1997 by two Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials. Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for complex trials in Rare Diseases, Oncology and Neuroscience.
We are looking for a clinical data manager with programming skills (SQL/SAS) , to be based in to be based remotely from home or one of our global office locations.
- Provide oversight and coordination of all DM activities in a project.
- Coordinate the Data Entry Clerks (DEC) and Database Developers (DBD) allocated to a project.
- Development of Case Report Forms (CRFs) for data collection.
- Creation, update and filing of project-related documentation (e.g. Data Management plan (DMP), Data Validation Plan (DVP), Data Entry Guideline, Database Specification Document (DBSD), Database Report (DBR)) in the DM TMF.
- Performing and documenting periodic QC of DM TMF files and follow up on all action items until closure
- Perform clinical database development, including data entry screen design, testing and validation based on the DBSD.
- Program, test and validate edit checks.
- Create the annotated CRF and other database-related documentation.
- Combine external data with the clinical database in cooperation with the Statistical Programmer.
- Perform initial coding of verbatim entries on adverse events, medical history and medications according to MedDRA and WHO-Drug dictionaries in the clinical database and forward to medical expert for quality control
- Export data from the clinical database to authorized recipients (e.g. in CDISC SDTM format).
- Generation of queries based on edit checks or errors and omissions identified during data entry and manual data review to resolve identified problems.
- Provide material for Data Review Meeting (DRM) and participate in DRM if required.
- Perform database lock and unlock procedures.
- Provide validated data exports from the EDC system or the clinical database to authorized recipients (e.g. related to SAE Reconciliation and medical coding where applicable).
- Communication with the sponsor in close cooperation with the PM.
- Attend meetings with project team and/or client
- Proven experience working within clinical data management and good technical skills (SQL/SAS)
- Ability to project manage client relationships and ongoing data management projects
- Experience of EDC systems and design of eCRF’s
- Able to work in a fast paced environment and manage multiple projects
- A minimum of a science based Bachelors degree
Why Should You Apply?
- We offer the chance to work in a growing Clinical data management team working on a wide range of projects and therapy areas, and across all phases
- We offer a friendly professional working environment
- We offer a competitive salary plus a good benefits package