Description
We are looking for a IDMP Technical Lead/Project Manager for a project close to Frankfurt:Technical Lead / Project Manager (m/f)
Start date: 01.03.2018
Duration: 31.10.2018
5 days per week - on site support 80%, 20% remote
Languages: English
Overview of role:
The technical implementation / project manager is supposed to lead a dedicated phase / workstream in the IDMP project to implement a data quality management system for Biopharma Research & Development. He/She will be responsible to design a flexible technical architecture supporting data quality analysis across the R&D system landscape. In addition, the technical lead shall derive a detailed implementation plan and drive it accordingly in close collaboration with the vendor and service providers. He/She shall also support the business in establishing a re-usable framework for business rules.
General Qualifications:
- Strong project manager and technical implementation lead experience within regulated industries for a considerable period of time (3+ years), preferably within pharmaceutical companies
- Proven specialist knowledge of pharmaceutical business processes e.g. Regulatory Affairs, Drug Safety and Clinical Operations
- 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 and quality oriented individual, who is closely involved and understands the business needs, scope and deliverables to be executed by the project
- 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
- Ability to react quickly and appropriately as required; knowing when to change the approach and when to persist with chosen approach
- Excellent communication skills, both one on one, and in larger groups. The technical lead should be able to distinguish relevant from non-relevant information and communicate in a concise manner that is both informative and thorough
- Experience in capacity and financial planning of projects
- Demonstrated track record of efficiently and effectively managing a project
Project Requirements:
- Proven specialist knowledge of data quality solutions (from vendors like Informatica, SAS or Information Builders) in the pharmaceutical industry
- Extensive experience in designing technical architectures for integration and data quality platforms
- Experience in developing a re-usable business rules framework
- Optional: Proven knowledge of IDMP (Identification of Medicinal Product), EMA SPOR model
and Regulatory Information Management Systems
Logistical Requirements:
- Willingness to be on site - this would be a minimum of four days a week on a weekly basis
- Ability to travel as needed to different locations or vendor sites
Project Tasks:
- Derive project implementation plan that includes prioritizations, timelines, cost estimations, needed resources
- Design flexible technical architecture to supporting data quality analysis across the R&D
system landscape - Coordination of all project resources to ensure timely delivery of project activities
- Maintenance of project plan, managing the project according to that plan, anticipating deviations to that plan, and estimating any corresponding impact on budget and resources
- Coordinating the activities of project resources according to the project plan and providing oversight for timely completion of those activities at the right quality level
- Management of stakeholders via core team meetings, etc. to ensure alignment, escalation, and resolution of any risks or issues arising on the project
- Responsible for maintenance of project budget and financials
- Responsible for coordinating the resolution of all project activities, leading issues to a
successful resolution, and taking ownership for the responsibility for the delivery of some of the activities
- Managing project risks and preparing the right response and mitigation approach for these
If you are interested, please send an email to with your CV and availability.