In scope of the Clinical Trial Biosample Management & ICF Tracking project we are looking for a senior project lead (full time) specialized in GCO (Global Clinical Operation) & IT Application Implementation in BioPharma in a highly regulated (GxP) & validated environment. The project lead is supposed to lead complex & crossfunctional dedicated workstreams in the Clinical Trial Biosample Management & ICF Tracking project to implement a pre-selected software solution, including Datasourcing & integrations from Design to Go-Live resp. Project Closure in Biopharma Research & Development.
Following SDLC & RACI principles and deep seeded knowledge in our customer’s internal IT processes; e.g. a prior successful implemetation (Go-Live/project closure) within Scope, Budget & Timeline, are a definite plus.
The project lead will be leading a multinational-crossfunctional team. Ideally He/She shall also be able to take on senior business analyst activities, such as to consult with the business, and other SME’s to define capabilities, use cases and other user oriented designs (user requirements) & new processes. It is the role of the PL/BA to understand the project, to analyze and design end to end key business processes and provide conceptualizations of platform/systems solution design.
In addition, he/she shall derive the long-term roadmap/project plan for the rollout and the implementation plan that includes prioritizations, timelines, cost estimations and needed resources. In terms of general approach and style, the most important characteristics for IT PLs are a strong sense of accountability and dedication to the project with a collaborative, inquisitive and detail orientated working style, and the willingness to push through challenges and difficulties.
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, implementation & integration plan including long-term system life-cycle map
- Derive detailed project implementation plan that includes prioritizations, timelines, cost estimations, needed resources
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 our customer’s 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
Project start: 01.11.2018
Project end: 30.06.2019
Availability: full time on site (20% remote)