We have partnered with a specialist UK-based CRO with particular expertise in oncology, rare diseases and advanced, cell and gene therapies. This organisation has rapidly expanded in recent years becoming a highly successful niche CRO with a global network of clinical development experts.
This is a fantastic opportunity to to help drive new technologies and interesting studies, contributing to the growth and development of a data management department to support the commercial success of an innovative and forward-thinking business.
As a Lead Data Manager you will lead interesting, mainly early phase clinical trials. As a key member of the clinical study team, you will establish, perform and oversee the setup, maintenance, control and validation of clinical study databases ensuring compliance with SOPs and applicable regulatory guidelines at all times. The Lead Data Manager will also have the opportunity to contribute to the DM capability and processes to help shape this growing team in the current technology driven environment.
- Define and manage clinical data management timelines on multiple studies or programmes
- Coordinate/perform all CDM activities for assigned studies/programmes, including eCRF design, EDC system set up, user acceptance testing, users training, data review, query generation and data coding
- Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
- Ensure appropriate study specific training is provided to assigned clinical study teams
- Generate data analysis status reports on clinical studies for the clinical study teams
Skills and Experience:
- A scientific background, ideally university level and GCP trained
- A minimum of 5 years’ experience in clinical data management at a CRO or Pharma with strong experience using major EDC systems and related tools and technologies
- Experience in leading data management studies and teams to timely delivery of quality databases that meet regulatory requirements
- Knowledge and experience of using CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml
- Experience as primary representative of Clinical Data Management project team
- Communication skills and an ability to quickly build relationships
To find out more about this fantastic opportunity please contact Erick Semerene at RBW Consulting.
At RBW Consulting LLP, every one of our consultants has one specific area of expertise ensuring they excel in helping Pharmaceutical Professionals find the jobs they are looking for in the industry.