Beschreibung
Task:Implementation of pre-selected vendor solution from Biofortis (labmatrix) on a cloud based AWS platform
- Derive project plan for implementation of solution / vendor selection that includes prioritizations, timelines, cost estimations, needed resources
- Resource Allocation
- Steering Committee & Stakeholder management
- Budget/forecast control
- Project Management reporting updates
- Create capabilities and use cases
- Define to-be processes
- Translate to-be process in viable user requirements
- Categorize and prioritize requirements
- Define business critical success factors
- Design long-term roadmap, implementaion & integration plan including long-term system life-cycle map
- Derive detailed project implementation plan that includes prioritizations, timelines, cost estimations, needed resources
Requirements (Must have):
SDLC process with Stage Gates & GxP Validation/Qualification Environment
- Proven specialist knowledge of Global Clinical Operation & in General R&D in the pharmaceutical industry
- Proven experience in computer system validation in the pharmaceutical industry
- Extensive experience in complex project management including defining capabilities, use cases and user requirements (based on to-be processes)
- Ability to efficiently conduct a fit gap analysis of internal solutions based on defined user requirements
- Prior experience in successfully implementing an IT project in Global Clinical Operations
- Prior experience in developing a long-term roadmap rollout the solution across the organization
- Optional: Proven knowledge of Biosample & ICF tracking process including CROs; central lab process
- Optional: Proven knowledge of diagnostic systems/test centers including LIMS systems
General Qualifications:
- Strong project management/lead & business analyst experience within regulated industries for a considerable period of time (10+ years), preferably within pharmaceutical
- Proven specialist knowledge of pharmaceutical business processes e.g. Regulatory Affairs, Drug Safety, Clinical Operations
- Prior experience in completing a full computerized systems validation and testing methodology with awareness of the risks, issues, complications, and activities involved in these processes
- Prior experience working within a validated and qualified systems environment, and an understanding of the challenges and complexities that this can bring to project delivery and timelines (optional on a case by case basis or industry)
- Ability to establish and promote an effective project governance structure
- Detail oriented individual, who is closely involved and understands the business needs, scope and deliverables to be executed by the project
- Ability to define and adjust business processes by leveraging design thinking and other requirements elicitation techniques to best capture business needs.
- Collaborative working approach, willingness to engage stakeholders on a consistent basis to build ongoing relationships to further define and refine business needs onsite and remotely as needed
- Excellent communication skills, both one on one, and in larger groups. The PL should be able to distinguish relevant from non-relevant information and communicate in a concise manner that is both informative and thorough
- Experience in working with third party vendors and SME’s to deliver proof of concepts and
other study or PL project activities
- Experience in capacity and financial planning of projects
- Demonstrated track record of efficiently and effectively managing a project
Beginn: 01.11.2018
Dauer:
Branche: Chemie/Pharma