Project Manager

Key Responsibilities

Project Leadership & Delivery

• Lead end-to-end planning, execution, monitoring, and closure of biometrics-focused projects (statistical programming, biostatistics, data management, and related services).
• Oversee project activities to ensure deliverables meet client requirements, regulatory expectations, and internal quality standards.
• Develop detailed project plans including timelines, resource assignments, milestones, and risk mitigation strategies.
• Drive project governance through regular status updates, issue tracking, and proactive communication.

Client Engagement

• Serve as the primary point of contact for clients across project timelines.
• Facilitate project kick-off meetings, milestone reviews, and ongoing client check-ins.
• Build and maintain strong client relationships to ensure satisfaction and repeat business.

Project Coordination

• Collaborate closely with technical leads across programming, biostatistics, and data management to align resources and manage workloads.
• Track team performance, identify bottlenecks, and escalate issues when needed.
• Ensure adherence to standard operating procedures (SOPs) and project management best practices.

Quality

• Identify project risks and develop mitigation and contingency strategies.
• Ensure deliverables meet quality standards and follow regulatory guidelines (e.g., CDISC, FDA/EMA expectations, GCP principles).
• Support internal audits and continuous improvement initiatives.

Budget & Contracts

• Track project budgets, forecast resourcing needs, and monitor scope changes.
• Prepare progress reports and participate in client negotiations regarding scope, timelines, or resource adjustments.
• Partner with internal stakeholders on contract management and invoicing activities.

Qualifications

Education

• Bachelor's degree in Life Sciences, Statistics, Computer Science, Public Health, or a related field.
• Masters degree preferred

Experience

• 4+ years of project management experience in a CRO, pharma, biotech, or life sciences environment.
• Experience managing biometrics-focused projects (statistical programming, biostatistics, data management) strongly preferred.
• Clinical trial experience is a plus

Skills & Competencies

• Strong understanding of clinical development, biometrics workflows, and regulatory expectations.
• Excellent communication, client management, and stakeholder engagement skills.
• Solid organizational abilities with a track record of delivering high-quality projects on time.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira, Confluence).
• Ability to manage multiple projects simultaneously in a fast-paced, global environment.
• PMP, PRINCE2, or Agile certification is a plus.