Clinical Data Team Lead
An exciting opportunity has arisen for a Clinical Data Lead to join a large biotech in the UK, you will be responsible for all data management aspects of the assigned clinical studies from initiation til closure ensuring that clinical data completeness is compliant with the local and global regulations.
- Acts as an interdepartmental and client liaison for all DM study activities.
- Produces project-specific status reports for management, PM and/or clients on a regular basis.
- Monitors and analyzes study metrics and escalates per the organiztion's risk management processes.
- Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required.
- Assists with project forecasting of hours and identification of resource requirements.
- Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process.
- Leads, high volume/highly complex studies.
- Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget.
- Mentors junior level staff on all associated tasks within a study.
- Assists with administrative and financial oversight for allocated projects.
- Communicates with management regarding all data management activities within their studies.
Skills and Requirements
- Experience as a Clinical Data Lead
- Technical knowledge of SDTM (Study Data Tabulation Model) and CDISC Standards is required
- Review define.xml files and identify error messages
- Run and review the Pinnacle 21 reports
- Involved in creation of the DTA
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.