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