MakroCare | A MakroGroup Company |
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Job Description & Responsibilities:
Setting up IRT studies according to documented specifications and Participating in the development of user requirement specifications
- Executing and documenting unit/module/form level testing to ensure requirements are
- Writing study-specific custom code & Authoring of study-specific custom code specifications
- Creating reusable database scripts for a data change process, Assisting in the maintenance of IRT studies
- Updating completed tasks on a project plan, Assisting other Operations Programmers as needed
- Serving as a primary point of contact for assigned projects & Keeping the department head advised of current issues
- Coordinates the activities around temperature excursion management and disposition, to update impacted inventory in IRT and other related
- Structures and manages integrated, multi-track projects & Leads the development and tracking of integrated project plans
- Provides project management support program leadership by helping to manage issues, risks, and re-planning efforts
- Work with all users, including end users, site administrators, and managers to get feedback on current operations and requirements for new features
- Analyze current architecture and standards and provide recommendations based on industry best practices
- Provide project planning materials, such as project plans and status/progress reports to leadership teams
- Manage scope - Gather, analyze, and document business and system requirements & establish and maintains processes to manage scope over the project lifecycle
- Develop and present solutions and recommendations & Use project scheduling and control tools to monitor projects plans, work hours
- Reviews project activities for compliance with procedures and
- Develops client and study-specific reports, Maintains Quality Service and Departmental Standards
Qualifications:
- Bachelor s degree in computer science or related field preferred
- 3+ years experience in system analysis in the support and maintenance of enterprise software systems, preferably in a pharmaceutical or regulated environment
- Working knowledge of object-orienting programming, Working knowledge of relational database design, and PL/SQL or T-SQL
- Excellent interpersonal and communication skills, both verbal and written
- Ability to maintain a professional and positive attitude, Ability to manage multiple projects
- Strong problem-solving and organizational skills, High attention to detail
Skills : clinical irt