Validation Project Manager

Project Description:  Technical Project Manager with extensive validation experience managing the delivery and implementation of complex scientific information technology systems, and overseeing validation of applications in a regulated environment.

The successful candidate will manage and participate in deployment and qualification activities for systems supporting the pharmacokinetic data management of clinical trials. Specific projects include completing minor upgrade and qualification of vendor software components, project management including validation documentation of upgrades to a major vendor package, and validation of version releases of an internally developed software package.
 
- Full systems implementation life-cycle with emphasis on finalizing and documenting requirements to support a diverse client group spanning multiple sites and departments.
- Partner with Quality Assurance in planning and executing validation activities including validation / user acceptance testing planning, writing scripts, facilitating test execution, and summarization.
- Managing scope, quality and timeline in conjunction with software vendor deliverables.
- Create and maintain project plans, identify and manage risks and issues.
- Coordinate infrastructure support groups and IT technical staff to ensure environment planning and configuration management activities support the needs of the project.

 

Required Skills:  - Must have project management experience in the pharmaceutical industry in a regulated environment. (3 - 5 years)
- Working knowledge of systems integration including implementation of systems (3 - 5 years)
- Experience with management of clinical data would be a plus
- Excellent oral and written communication skills including technical writing / documentation
- Ability to work independently with minimal supervision
- Ability to communicate effectively with technical and non-technical audiences