Key Responsibilities
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
Technical
- Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs
- Author, review and approve study TFL shells and dataset specifications
- Author, validate and document programs for datasets, TFLs and macros, applying good programming practice
- Identify data issues and outliers
- Complete, review and approve CDISC Validation tool reports
- Identify data and standards issues and resolve or escalate as appropriate
- Awareness of emerging standards and associated impact to ongoing and future planned trials
- Maintain proficiency in R and awareness of developments
- Maintain study master file documents and any other documents that are required to be audit ready
People Management
- Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports
- Provide coaching and mentoring of staff to achieve “excellence”. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs
- Interview and effectively on-board and integrate new staff members
- Provide programming technical leadership and coaching
Project Management
- Oversight of key client projects/portfolios.
o Being Veramed Project Manager on client accounts and projects
o Maintain the project plan
o Proactive management of resource, scope change and risks
o Manage the delivery of projects to budget
o Manage client expectations and issue resolution
General
- Lead internal and client study, project and cross functional team meetings effectively
- Present study updates internally and at client meetings
- Share scientific, technical and practical knowledge within the team and with colleagues
- Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
- Build effective collaborative working relationships with internal and client team members
- Ensure learnings are shared across projects or studies
- Develop and provide internal technical training where appropriate
- Lead process improvement initiatives
Key Responsibilities
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
Technical
- Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
- Author and review simple and complex study TFL shells
- Author and review simple and complex dataset standards
- Perform data checks and data exploration (e.g. using frequencies, histograms)
- Program and QC routine and ad hoc datasets and TFLs (in R) following specifications, applying good programming practice
- Complete and review CDISC Validation tool reports
- Ensure the appropriate standards are being applied and adhered to
- Familiarisation with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival)
- Review of project management related documents
- Maintain study master file documents and any other documents that are required to be audit ready
Project Management
- Act as Lead Programmer and/or Veramed Project Manager for client projects and studies
- Maintain the project plan
- Proactive management of resource, scope change and risks
- Manage the delivery of projects to budget
- Manage client expectations and issue resolution
General
- Lead internal and client study team meetings effectively
- Present study updates internally and at client meetings
- Share scientific, technical and practical knowledge within the team and with colleagues
- Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
- Build effective collaborative working relationships with internal and client team members
- Seek opportunities to develop innovative ideas, sharing when appropriate
- Line management or mentorship of more junior team members
- Contribution to development of internal training materials
- Contribution to internal process improvement initiatives