Veramed is a specialist contract research organisation (CRO) to the pharmaceutical industry, focused on delivering high quality statistics and programming for the reporting of Phase I-IV clinical trials across a variety of therapeutic areas. The projects and clients we work with provide a varied and exciting challenge; this in turn enables us to help develop and enhance our employees’ capabilities and gives opportunities for growth.
This role serves three key roles within the business: a technical role, a supervisory role (i.e. line management and/or project management), and a business role.
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
- Provide consultancy support for existing and / or new clients and oversee technical consultancy projects.
- 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 SAS programs for datasets, TFLs and macros, applying good programming practice.
- Complete, review and approve CDISC Validation tool reports.
- Identify data and standards issues and resolve or escalate as appropriate.
- Lead internal and client study, project and cross functional team meetings effectively.
- Share scientific, technical and practical knowledge within the team and with colleagues.
- Awareness of emerging standards and associated impact to 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.
- Perform work in full compliance with applicable internal and client policies, procedures, processes and training and ensures compliance of direct reports.
- Line management of medium-sized team of statisticians, programmers and other technical staff, including line managers. 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.
- Oversight of key client projects/portfolios.
o Client account manager on key client accounts and projects.
o Responsible for project related governance.
o Proactive management of resource, scope change and risks.
o Manage the delivery of projects to budget.
o Manage client expectations and issue resolution.
MINIMUM QUALIFICATION REQUIREMENTS:
- BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience).
- At least 10 years of relevant industry experience.
- Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs.
- Awareness of industry and project standards & ICH guidelines.
- Excellent verbal and written communication skills.
- Interpersonal/teamwork skills for effective interactions.
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
- Demonstrated problem solving ability and attention to detail.
- Management and leadership experience.
- Ability to make informed and appropriate decisions.
If you wish to apply for this role please follow the steps below to register with Veramed Recruitment, and upload your CV and cover letter for review. You must complete both steps of this process to complete your application.