IT R&D Project Manager

Job Req #: 21-12521Job Description: IT R&D Project ManagerLocation: RemoteJob Type: Contract Key Responsibilities: This position will be responsible for managing projects as part of the Research, Drug Development and PDM department. The role will be responsible for facilitating, directing, reporting and managing the implementation of specific projects such as Rave EDC, Study Builder, ClinPharm solutions and other assigned projects. This position will also manage key meetings and serve as the IT liaison translating business requirements into technical solutions and processes.This position requires a detailed oriented, Hands On PM capable of managing multiple projects while developing business relationships with key R&D stakeholders. Good knowledge of GxP Compliance and a passion about system delivery and implementation is required along with the ability to lead cross-functional teams including our SaaS vendors.

• Pro-actively lead effort in the following areas: Coordination of project activities with business SMEs, IT Architects, IT Business Analysts, develop and manage detailed project plans, lead diverse project teams, monitor progress and drive the delivery with focus on adhering to schedule.
• Facilitate sessions for use-cases and configuration workshops as necessary.
• Develop or review the necessary documentations (e.g. Project Charters, Budget Trackers, Status Dashboards, Timeline visuals , Statements of Work, Service Level Agreement and necessary SOPs).
• Professionally prepare presentations for IT, Business executives to status, roadmap, strategize programs and projects.
• Ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle, working tightly with IT Validation, SMEs and Nektar Quality Teams.
• Drives and coordinates system related Change Requests and Deviations / CAPAs in accordance to governing GxP procedures.
• May participates in product evaluations (RFP/RFI) , vendor selection, price negotiations, support options and fosters vendor partnerships.
• Coordinates implementation of enhancements/upgrades and provides backup for other IT SMEs as required.
• Responds to critical issues during off hours when necessary.
• Work closely with the IT platform leads to apply standards and evolve process to ensure solutions abide by best practices and industry standards.

• Bachelors Degree in Computer Science, Information Technology, or related discipline.
• 8-10 years of experience in the Information Technology field.
• 7 yrs of GxP Project implemetation experience
• PMP certification desired
• Strong knowledge of procedures/best practices related to FDA Regulations, EU GMP Annex 11, 21 CFR Part 11, Computer System Validation, GAMP 5, cGxP (cGoogle Cloud Platform, cGLP, cGMP) practices
• System lifecycle (SLC) experience in a regulated environment.
• Familiar with Operating Systems, Infrastructure, VMWare Virtualization, and cloud-hosted technologies
• Ability to articulate technical problems and business value to a wide business audience.
• Ability to troubleshoot issues and work independently with minimal supervision.
• Excellent verbal and written communication skills.
• Self-motivated with high degree of initiative, excellent follow-up skills, along with strong analytical skills