Associate Director, Clinical Project Manager

The Associate Director, Clinical Project Manager is responsible for the overall coordination and management of clinical trials from start up through close out activities (allocated Phase I through IV Clinical Trials that may be local, regional, or global in scope). Directs the technical, financial, and operational aspects of the projects, securing the successful completion of clinical trials.  Partners with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented. Ensures that all project deliverables meet the time/quality/cost expectations. The Clinical Project Manager, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet company expectations. This position reports to the Director, Clinical Program Management and is a remote based position with a corporate headquarters in the Foster City, CA and Parsippany, NJ.

REQUIREMENTS/QUALIFICATIONS

Key Competencies:

  • Primary oversight of assigned clinical study budgets, timelines, and deliverables with effective task delegation amongst cross-functional teams
  • Driving internal and external teams to meet project deliverables, performance targets, and corporate goals
  • Leading internal study working group by organizing meetings, timeline and action item management, monitoring issue resolution, etc.
  • Ownership and maintenance of project plan timeline in Smartsheet; ensure successful design, implementation, tracking, and revision of project plans for assigned projects
  • Identifying risks and mitigations, ensuring routine assessment by appropriate teams
  • Oversight and management of vendor activities, contracts, budgets
  • Promote and build effective teamwork and communication with internal and external teams
  • Identify key resource needs and risks, developing mitigations when needed

EXPERIENCE AND COMPETENCIES

The successful candidate will be able to demonstrate the following:

  • BA/BS in biological sciences or related field
  • Minimum 6 years project management experience in pharmaceutical/ biotechnology industry with knowledge of early to late phase development for drugs, biologics, and/or devices
  • Thorough knowledge of project management processes
  • Successful management and leadership of multidisciplinary project teams
  • Thorough knowledge of ICH Guidelines and GCP/GMP including international regulatory requirements
  • Solid understanding of how to craft and manage a project plan and budget
  • Global and complex clinical trial experience preferred
  • Proficient is use of MS office programs (Excel, Word, PowerPoint, etc.)
  • Progressive experience managing complex/multiple clinical studies in various phases of development
  • Demonstrated leadership and cross-functional interactions within a matrix project team environment
  • Excellent cross-functional team management, ensuring effective teamwork and communication (listening, verbal, written)
  • Proficient in applying project management best practices and use of tools for managing project activities
  • Effective vendor management experience, including scope, budgeting, and contracting activities
  • Proficiency with setting up program level budgets, timelines, and tracking variances
  • Ability and desire to persuade, convince, and influence others
  • Effective and appropriate delegation and prioritization skills
  • Excellent attention to detail and highly organized