Associate Project Manager Clinical Trials

U441 (FCRS = US441) Navigate BioPharma Services, Inc.Carlsbad, CA
444d$66,000 - $99,000

About The Position

The Associate Project Manager at Navigate BioPharma Services will oversee the management of clinical trial project lifecycles, ensuring timely delivery of services and adherence to quality standards. This role serves as a primary point of contact between sponsors, external stakeholders, and the Navigate business, facilitating effective communication and project execution.

Requirements

  • Bachelor's degree in a science-related field.
  • 2+ years clinical trial project management experience preferred and/or relevant experience managing project timelines, budgets, and scope in a customer-facing role.
  • 3+ years related project management experience in a relevant industry preferred.
  • Strong customer and service focus.
  • Strong communication skills to ensure project schedules and client expectations are met or exceeded.
  • Demonstrated ability and success in fostering internal and external collaborations.
  • Strong scientific background is essential.
  • Strong organizational and program management 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, or experience with, financial modeling strongly desired.

Nice To Haves

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

Responsibilities

  • Establish and maintain effective communication channels with relevant internal and external project stakeholders throughout the entire 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 stays within budget and identify scope changes for appropriate modifications in change orders.
  • 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 a larger number of clinical trial projects and/or multiple project portfolios, including those that require partner lab set-up and testing.
  • Demonstrate critical thinking skills and strategic planning in project execution and risk management.

Benefits

  • Competitive salary range of $66,000.00 - $99,000.00
  • Commitment to Diversity & Inclusion
  • Accessibility and reasonable accommodations for individuals with disabilities
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