What are the responsibilities and job description for the Senior GxP IT Project Manager position at One Vector?
We’re seeking an experienced Senior Project Manager to lead IT and digital initiatives across biotech clients in the clinical or preclinical phases. The ideal candidate will be a results-oriented leader with a strong blend of business acumen, technical knowledge, and exceptional communication skills. This role involves driving execution across cross-functional teams, coaching junior PMs, and delivering compliant, validated systems that support R&D and operational growth.
Key Responsibilities
- Lead project planning activities including timeline definition, funding needs, resource assignments, and scoping deliverables.
- Identify, schedule, and track project milestones, activities, and tasks using recognized project planning tools (e.g., MS Project, SmartSheet etc).
- Provide leadership and motivation to internal teams and external stakeholders throughout the project lifecycle.
- Coordinate the development of work plans and effort estimates across project iterations or phases.
- Review and approve project plans developed by external vendors, partners, or consultants.
- Develop and execute project communication strategies to ensure alignment and transparency with stakeholders.
- Direct and coordinate the activities of cross-functional project teams and external vendors to ensure projects progress on schedule and within budget.
- Proactively identify and track project risks, developing and implementing effective mitigation plans.
- Monitor project execution for quality, compliance, and consistency in reporting and documentation.
- Drive projects to completion on schedule and within budget while aligning to business and IT goals.
- Review project status reports, resolve roadblocks, and adjust plans as necessary.
- Ensure all project deliverables, especially GxP validated systems, comply with FDA and other regulatory requirements
Skills and Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Information Systems, or related field.
- Minimum of 8 years of experience in IT project management, with significant experience in the biotechnology/pharmaceutical industry.
- Proven experience leading & managing IT system rollouts, digital enablement, or data platforms in clinical/preclinical settings across multiple stakeholders across an organization.
- Demonstrated experience implementing GxP validated systems and a strong understanding of their regulatory requirements (e.g., 21 CFR Part 11).
- PMP, PMI-ACP, or equivalent certification preferred
- Strong communication and stakeholder management skills with the ability to lead cross-functional teams.
- Strong influencing and negotiation abilities in matrixed environments where resources are shared.
- Proven ability to manage customer expectations and build long-term client relationships.
- Experience in resource forecasting and portfolio planning across multiple projects.