Senior Project Manager Oncology - remote

Project Management Korea (the Republic of)


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Senior Project Manager to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

You’ll be doing:

  • Ensures successful management and coordination of efforts assigned to all members of the global project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
  • Ensures adherence to project budget and scope of work to realize project profitability
  • Ensures all project tasks are completed in accordance with project plans and in compliance with standard Premier Research processes, policies and procedures
  • Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally
  • Ensures adequate resourcing is available to meet project deliverables and milestones
  • Acts as the primary liaison between Premier Research and the customer for all assigned projects and chairs project team meetings and teleconferences
  • Manages the project team to ensure study progress is according to client and Premier Research requirements
  • Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
  • Develops project plans for all phases of the project lifecycle, including quality, risk management and proactive contingency plans, ensuring that issue escalation and resolution is clear
  • Facilitates communication across the project team and departments
  • Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews
  • Provides project progress reports, including performance against contract, customer expectations and project baselines
  • Monitors the quality of project deliverables and addresses quality issues with the appropriate team members
  • Facilitates resolution of project related conflicts with necessary corrective and preventative actions and alerts senior management to potential issues
  • Continually reviews and makes recommendations to ensure adequate resources are available to meet project deliverables and milestones
  • Oversees project documentation, ensuring Trial Master Files are completed by the functional groups and audit ready
  • Supports study audits and responds to audit reports
  • Monitors and manages customer satisfaction
  • Prepares forecasts for staff utilization over the life of the study
  • Reviews and approves project expenses and ensures all study related contractual and budgeting issues are addressed
  • Provides accurate information to ensure timely invoicing and allow for accurate forecasting
  • Identifies scope of work changes across all functional areas and secures Change Orders
  • Assists in Business Development activities, including proposal development and leading proposal presentations in partnership with Business Development and Scientific Account Leadership
  • Develops strong relationships with current clients to generate new and/or add-on business for the future
  • Ensures appropriate transition planning and stakeholder communication for any change in staff
  • Identifies, recruits and manages central vendors as required per project scope

You’ll need:

  • Undergraduate degree, preferably in a clinical, biological- or science-related field
  • Minimum 5 years relevant experience, preferably in a pharmaceutical company/medical device company/CRO including trial management experience
  • At least 2 years’ experience in clinical trial management as a Project Manager
  • Budget/finance/costing experience on a project level
  • Experience in coaching/mentoring other PMs
  • Experience in managing complex trials, multiple phases, and full lifecycle
  • Global experience preferred
  • Experience managing a study from start to completion
  • In depth, multiple therapeutic area and protocol knowledge
  • Knowledge of ICH/GCP regulations
  • Strong working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
  • Strong knowledge of the principles of project management
  • Strong knowledge of the clinical development process
  • Strong knowledge of full service functional areas
  • Knowledge of web based communication tools for conferences
  • Highly confident and effective presenter
  • Strong software and computer skills, including MS Office applications
  • Strong financial acumen