Description
We are looking for a
Systems Support Specialist (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM++
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Ensure efficient data management practices, standards, policies, procedures and protocols that assure ongoing data quality and integrity
- Help manage external vendor partners and help desk operations to ensure optimal support to internal and external end users, other partners and stakeholders
- Support the execution of clinical studies through innovative evaluation, deployment and management of clinical and non-clinical systems and provide centralized, cross-system, process and systems training support
- Act as a key liaison between study teams and support services, typically assigned responsibilities by therapeutic area, study phase or varying study demands, as business needs may dictate
- You will also play a critical role during systems User Acceptance Testing (UAT) planning and execution and will be expected to coordinate and facilitate UAT of clinical and non-clinical systems including Electronic Data Capture (EDC), Interactive Voice Response Systems (IVRS), ePRO, and other systems as appropriate
Ihre Qualifikation
- Educated to a degree level with any additional project management certifications, e.g., PMP, PgMP, PMI-ACP, PMI-RMP, PMI-SP an advantage
- Some advanced project management, clinical operations or clinical systems management experience across the software development lifecycle in a regulated IT environment is desired along with previous experience with help desk and/or user support
- Strong business acumen and in-depth knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., clinical development, regulatory, etc. and ability to proactively integrate multiple perspectives into business systems support and maintenance
- You should hold previous experience in development, deployment and/or maintenance of information systems in the pharmaceutical, biotechnology or related industry; to include user acceptance testing for computer systems
- Demonstrate clear knowledge of, and/or training in, regulatory and system compliance and hold a broad understanding of international regulations, processes and issues in drug development
- Fluent English required
Skills:
- Project manager
Keywords: Projektleiter