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, and CSRs
- Author, review, and approve study TFL shells and dataset specifications
- Author, validate, and document SAS programs for datasets, TFLs, and macros, applying good programming practices
- 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 on ongoing and future planned trials
- Maintain proficiency in SAS and awareness of developments
- Maintain study master file documents and any other documents that are required to be audit-ready.
Project Management:
Oversight of key client projects/portfolios. To include:
- Being Veramed Project Manager on client accounts and projects
- Maintain the project plan
- Proactive management of resources, scope changes, and risks
- Manage the delivery of projects to budget
- 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
Minimum Qualification Requirements
• BSc, MSc, or PhD in a numerical discipline (or relevant equivalent industry experience)
• At least 10 years of relevant industry experience
Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.
As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.