Safety Specialist - Technical Lead

Roles & Responsibilities:

• Monitor, manage, and ensure delivery of projects in a deadline-driven environment.
• Author Technical SDLC deliverables
• Technical assistance for testing preparation and implementation of enhancements
• Contribute to the creation of operational support documentation
• Drive technical delivery and accountability of internal staff as well as vendors and third-party project managers
• Enable early identification and appropriate escalation of risks and issues that require assistance, attention, or management resolution
• Presentation capability to build current to be architecture for Architecture Review Board
• Solution architect with exposure working with corporate EA and following their guidelines
• Lead capable to interact with internal as well as external vendor

Experience:

• 8+ years' experience as a technical lead/solution architect
• Experience working with SaaS and cloud (AWS) platforms
• Prior experience working with Clinical R&D Safety system/ Pharmacovigilance (PV) applications e.g. ARISg or similar
• Technical understanding of Safety system in term of infrastructure, and integration
• Experience working with SaaS vendor to manage various SDLC deliverables with GxP validated applications
• Strong interpersonal and teamwork skills as well as solid analytical and creative problem-solving skills
• Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
• Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
• Capable of multi-tasking across projects; highly organized
• Pharmaceutical or Clinical Research Organization industry experience
• Exposure with SaaS to Cloud migration is preferable
• Clinical system development experience preferable

Education:

• BA or BS required
• Certification in Computer Science, Business, or Life Sciences-related field