Senior Project Manager, FSP

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the primary contact for project leadership and sponsorship.

• Take ownership of overall project delivery concerning quality, timelines, and costs.

• Set and communicate customer expectations clearly to the project team.

• Lead cross-functional project teams and manage projects with increasing complexity.

• Ensure adherence to internal and external escalation procedures.

• Define roles and communication channels for secondary project leads when necessary.

• Manage financial stewardship, contract alignment, resources, budgets, out-of-scope activities, change modification processes, negotiations, and timelines.

• Identify risks and address issues at the project level using RBQM/RESOLVE methodologies.

• Ensure project team compliance with policies, SOPs, ICH-GCP, regulatory, and project-specific requirements.

• Provide mentorship to team members.

• Develop or contribute to initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor’s degree or equivalent, complemented by relevant academic or vocational qualifications.

• Over 8 years of relevant experience.

• Master’s degree is preferred.

• Background in biomedical or life sciences is advantageous.

• Proficient in technical and systems applications, including Microsoft Outlook, Word, Excel, PowerPoint, CTMS, Preclarus, and Clarity.

• Comprehensive knowledge of therapeutic areas and clinical development guidelines and directives.

• Advanced understanding of cross-functional project management principles, including time, quality, and cost.

• Strong financial acumen, encompassing budget, forecasting, and resource management.

• Excellent negotiation, analytical, strategic thinking, judgment, and decision-making abilities.

• Effective oral and written communication, presentation, interpersonal, customer service, and cross-cultural skills.

• Capability to delegate, prioritize tasks and resources, lead and coordinate cross-functional teams, and work independently with minimal supervision.

• Ability to adhere to organizational policies, SOPs, ICH-GCP, regulatory, and project-specific requirements.

• Capacity to work in office/laboratory and/or clinical environments, with potential exposure to biological fluids, infectious organisms, and electrical equipment.

• Competence to use required personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday schedule.

• Opportunities for collaboration and professional development.

• Mentorship opportunities available.

• Involvement in process improvement initiatives.

• Personal protective equipment provided as required.