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BioFire Diagnostics, LLC. Senior Project Manager, Clinical Affairs Microbiology Portfolio in Hazelwood, Missouri

The Senior Project Manager (Sr.PM), Clinical Affairs (CA) Microbiology Portfolio will manage a suite of clinical projects focused on the Microbiology franchise. The Sr.PM role requires an exceptional level of strategic thinking to lead the high-volume Microbiology clinical portfolio and experience in leadership positions with the ability to serve as a mentor to other team members within CA Program Management, represent the CA department to other departments and to the CA leadership team.

Primary Duties

  • Perform all work in compliance with company quality procedures and standards.

  • Build relationships with and gain trust of CA functional stakeholders and leadership team.

  • Set and lead Clinical Affairs project team meetings independently, assist others in running Clinical Affairs project meetings.

  • Own and lead project communication to align stakeholders and track goals/milestones.

  • Independently manage portfolio of complex clinical studies/projects.

  • Own and delegate project-related tasks, including (but not limited to): meeting minutes, timeline updates, and presentation preparation.

  • Align with Global PMO on project priorities ensuring proper time and resources allocated to progress projects.

  • Analyze relevant project information and brainstorm and implement solutions to potential barriers.

  • Recognize missing points of view in crucial decision-making conversations and ensure proper input to project decisions.

  • Maintain documentation; ensure all appropriate documentation is completed at project close.

  • Present projects’ progress, risks, and challenges to larger teams, including Project Governance teams and CA leadership team.

  • Teach/mentor other members of the team.

  • Regularly review colleagues’ documentation and presentations, and coach verbal communication.

  • Proactively consider plans for training, onboarding, mentorship, and development.

  • Seek out or create development opportunities for the others on the team.

  • Maintain a continuous improvement mindset, contribute to best practice alignment within the Clinical Affairs department and cross-functionally.

    Qualifications

  • B.S. life sciences, bioinformatics, or equivalent technical field required; relevant advanced technical degree a plus.

  • PMP from the Project Management Institute preferred.

  • 5+ years of project management experience in a regulated environment.

  • Microbiology experience required.

  • IVD experience preferred.

    Skills & Abilities

  • Knowledge of clinical study workflow and stakeholder functionality

  • Self-motivated and able to manage time effectively.

  • Effective team member and supports teams with a helpful attitude.

  • Ability to understand multiple perspectives.

  • Clear and transparent verbal and written communication; English fluency.

  • Critical listening skills with an ability to recognize and summarize important information.

  • Ability to stay calm and maintain a positive, pragmatic approach in stressful situations.

  • Flexibility in adjusting to changing department/global priorities.

  • Excellent organization skills and precise attention to detail.

  • Critical and innovative thinker.

  • Proactive.

  • Coachable.

  • Inquisitive and eager to learn.

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