Director Project Management - Rare Disease & Pediatrics- Remote, US

Fortrea is hiring a Director of Project Management to lead operational delivery for complex clinical studies and programs in rare disease and pediatrics. The role serves as a primary client lead, manages risk and escalations, oversees project teams and talent development, and supports client relationships and business development.

Responsibilities:

• Primary client contact for assigned clinical studies or programs, working independently with generally highly complex strategy, multiple vendors, sub-CROs with no planned oversight. May have other Project Managers working in a matrix environment with program level oversight
• With a primary focus on operational delivery, develops strategies to manage risk and control and improve operational execution. Utilize staff to maximize contribution and organizational effectiveness
• Contributes to resolution of escalation of project level issues
• Oversees the line management and talent development of Individual Contributors and/or Managers of Project Managers
• Success in the role involves leveraging experience to drive solutions, developing and maintaining strong relationships with key stakeholders at all levels of the business, and expanding client portfolios as well as contributing to growth objectives through training, allocation and ongoing mentorship of experienced team members
• Leads the project team to facilitate the successful design, implementation, tracking and maintenance of all project plans, adhering to professional standards and SOPs, according to contracted timelines and budget
• Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client
• Proactively lead quality control and risk assurance activities to meet regulatory, internal and client requirements
• Fosters positive client experiences through effective communication and collaboration
• May serve as a primary contact for a strategic client relationship. Develops and manages strategic relationship level fundamental documents, including charters, MSA negotiation, rate card input, operations and quality plans, etc. Initiates process improvement to address variance
• Designs delivery strategy for large scale bid defense and performs other business development activities
• Attracts, selects, onboards, develops and retains high performing talent, strengthens talent bench and succession
• All other duties as needed or assigned

Requirements:

• Fluent in English, both written and verbal
• Extensive knowledge of the clinical development spectrum and ICH GCP
• Advanced proficiency in organizational and time management skills
• Demonstrates sound judgment in high-stakes or ambiguous situations
• Exceptional presentation skills for all levels including internal and partner executive leadership
• Actively contributes to continuous improvement efforts and strategic planning activities
• University/college degree in life sciences
• Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO including at least six (6) years of full project management responsibility
• Minimum of four (4) years direct or indirect supervisory experience
• In lieu of above experience requirement, a combination of other relevant and equivalent experience may be considered
• Masters
• Preferred therapeutic areas: rare diseases, neonatal and infant pediatric studies
• PMP or certified in clinical research