The Government Health and Safety Solutions Operation is seeking a Senior Project Manager, contingent upon contract award, in Rockville, MD.
We are looking for an individual to manage the technical delivery of R&D Quality and Regulatory value stream and its associated Platform for an NIH customer.
- Manage a team that will implement, integrate and maintain regulatory and quality Commercial off-the-shelf (COTS) systems specific to drug development, clinical, and FDA submission processes.
- Manage development and implementation life cycle, focusing on project staffing, scheduling and the on-time delivery of high quality, reliable and easy to use systems in an Agile development environment
- Establish, document, and manage the scope, schedule, and resource allocation across all tasks and sustaining activities to ensure successful project execution
- Evaluates, monitors, or ensures compliance with regulations, policies, standards or procedures associated with all aspects of project;
- Drive innovation and integration of new technologies and processes into projects and activities.
- Collaborate and communicate with business stakeholders across multiple divisions in gathering requirements, product rollout, training and change management to ensure smooth implementation of the COTS product ensuring compliance with regulatory requirements.
- Collaborate with technical team to establish best practices for COTS product implementation and engineering, business analysis, solution designs, enterprise integration and project management delivery practice in Agile DevOps Delivery Model.
- Assesses business and technical requirements and business priorities as well as leads high-level investigations or analysis aligned to the strategy.
- Leads, Coaches and Mentors a team of software integration engineers, system administrators and business analysts while applying business acumen to deliver high-valued results.
- Building strong strategic relationships with complex customer groups and senior stakeholders, developing a deep understanding of the short-term and long-term business direction and IT strategy.
- Managing change by presenting and gaining buy-in from senior business stakeholders for the product implementation, leveraging domain knowledge to gain credibility, trust, and commitment.
- Collaborate closely with the cloud platform management team to ensure availability and security of the environment per NIH policies
- Coordinate with the COTS vendor for software upgrades, resolving issues, training etc.
- Coordinate and lead the training and stakeholder reach out tasks
Required Educational and Experience Requirements:
- B.S. in Computer science or equivalent with 12 + years of experience
- PMP certified
- Experience managing project that included COTS software products implementation and integration in a large environment.
- Experience with managing changes and obtaining stakeholder buy-ins in a large multi division environment
- Proven track record to collaborate with stakeholders to help them understand the product’s key capabilities and benefits; understand their needs to enhance adoption of IT Solutions.
- Experience working in IT GxP Validated environment adhering to good practices for – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5) including ITIL Service/Change Management framework.
- Experience developing program objectives, success measurements or key performance indicators (KPIs).
- Experience with release planning, demonstrations, and retrospectives with development teams and other stakeholders.
- Experience in Agile Methodology for backlog tracking, burn down metrics, velocity, and task definition.
- Experience with complex facilitation and dependency management techniques (cross team, cross department).
- Experience Driving delivery and continuous improvement by utilizing feedback and metrics (quality, delivery rate, etc.) to identify areas of opportunity.
- Experience managing projects with cloud deployment and ongoing maintenance.
- Experience with program reporting including Task Management, Funding and Expenditure, Risk Management, Staffing, Performance Requirements, and Quality Assurance among other required reporting that may be needed
- Excellent communication and presentation skills
- Life sciences domain knowledge and FDA regulatory requirements and submission protocols
- Experience supporting regulatory compliance software systems.
- Prior experience with Health and Human Services agencies, preferably with NIH
External Referral Bonus:Ineligible
External Referral Bonus $:
Potential for Telework:Yes, 25%
Clearance Level Required:Public Trust
Travel:Yes, 10% of the time
Scheduled Weekly Hours:40
Job Family:Proj and Prog Management
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