Project Manager - Clinical Trials

Novartis - Carlsbad, CA

Full-time - Mid Level

Carlsbad, CA

Chemical Manufacturing

About the position

The Project Manager at Navigate BioPharma Services will oversee the lifecycle of clinical trial projects, ensuring timely delivery, budget adherence, and quality standards. This role serves as the primary contact between sponsors, stakeholders, and the Navigate team, managing both assay development and clinical trial projects in a regulated environment.

Responsibilities

• Establish and maintain effective communication channels with internal and external project stakeholders throughout the project lifecycle.
• Disseminate project updates, issues, and modifications to teams in a proactive and timely manner.
• Monitor project timelines to ensure on-time execution and completion of project deliverables and milestones.
• Collaborate with sponsors and internal teams to accurately forecast project billables and complete billing.
• Control project scope to ensure the project remains within budget and identify scope changes for appropriate modifications.
• Proactively identify risks, develop mitigation plans, and resolve issues.
• Escalate critical problems to management and project stakeholders.
• Author study-specific documentation, including presentations; lead internal and external meetings, and develop agendas and minutes.
• Manage assay development projects that may have IDE or IVD requirements, including those with product development under design control.
• Lead timeline management for assay development projects, coordinating and aligning stakeholders for joint success.
• Manage multiple clinical trial projects with higher complexity, including partner lab set-up and real-time sample incident resolution.
• Demonstrate critical thinking skills and strategic planning in project execution and risk management.

Requirements

• Bachelor's degree in a science-related field.
• 3+ years of clinical trial project management experience preferred.
• 4+ years of related project management experience in a relevant industry preferred.
• Strong customer and service focus is essential.
• Strong communication skills to meet or exceed project schedules and client expectations.
• Demonstrated ability to foster internal and external collaborations.
• Ability to influence without authority and work in a team setting.
• Strong scientific background and organizational skills.
• Knowledge of logistics and clinical trial operations.
• Knowledge of FDA regulation of clinical trials; GCP and 21 CFR is strongly recommended.
• Product development under design control desired.
• Project management certification is a plus.
• Demonstrated understanding of financial modeling strongly desired.

Nice-to-haves

• Related Project Management coursework and/or experience strongly desired.

Benefits

• Comprehensive benefits package including health insurance, retirement plans, and professional development opportunities.