GMP Project Manager - Human Vaccine Institute
- Location: Durham, NC
- Posted: Dec 30, 2019
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nations top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
GMP PROJECT MANAGER
The Project Manager position will be responsible for working with the Duke Human Vaccine Institute (DHVI) GMP Portfolio Manager in the daily project management of assigned projects within the GMP Program (DGP) facility. This positions responsibilities will include leading project-based teams within the DGP. As the project team lead, responsibilities will include managing and organizing kick-off meetings with project sponsors, developing and managing project timelines and project plans using traditional project management tools.
Work with cross-functional project teams within the DGP (Process Development, Analytical Development, Operations, Quality and Program Management) to manage all aspects of project management from pre-kick-off project initiation/ planning to project closeout and CMC submission. Create and track project timelines, Gantt charts, and workflows.
Manage and coordinate the pre-award proposal process, working with individuals at various levels in the organization to ensure successful integration of all parts and ensure full compliance with all funding solicitation and sponsor requirements.
Provide routine project updates including project plan timelines, risks, action items, communication plans and escalations as required. Organize and facilitate internal and external stage gate reviews for assigned projects.
Conduct monthly project reviews including project plan updates, project financial status, maintain and update meeting minutes and collective team sites per sponsor requirements. Proactively measure and monitor project health according to established criteria.
Assist GMP Portfolio Manager in implementation of routine project management processes and procedures for effective and efficient project and program management.
Perform other duties as assigned by DHVI leadership and the GMP Portfolio Manager (or designee).
Work requires a minimum of a Bachelors degree in healthcare, engineering or scientific discipline. Masters degree preferred; PMP Certification is a plus.
Work requires 6+ years of industry experience in GMP manufacturing operations with proven team leadership and hands-on project management experience. Advanced degree can substitute for some of the experience requirement.
PREFERRED KNOWLEDGE, SKILLS, & ABILITIES:
Knowledge and proficiency using project management programs (i.e., MS Project and/or Primavera or equivalent)
Strong leadership and team facilitation skills with demonstrated ability to collaborate effectively across organizational levels and functions
Proven ability to utilize project management principles, tools and techniques in project planning, execution, control and risk management
Strong verbal and written communication and presentation skills
Display highly effective time management, organizational, critical thinking and problem solving skills with a keen attention to detail and consistent follow-through
Ability to thrive under deadlines and pressure
Requires a Bachelor's degree in a related field; Master's degree preferred.
6 years directly related data management experience to include at least 2 years of administrative, supervisory or project management experience. Experience managing multiple projects & teams and experience supervising staff, particularly departmental teams or sub-groups are highly valued. Certified Clinical Data Manager (CCDM) designation is strongly recommended. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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