Clinical Project Risk Manager - Remote (East Coast, US or Canada)

Project Management United States


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 Clinical Project Risk 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.

The Clinical Project Risk Manager supports implementation of a fit-for-purpose Risk-Based Quality Management (RBQM) methodology for all Premier’s clinical studies. The Manager / Sr. Manager illustrates an established project and program management background and has a good working knowledge of the different project management methodologies and disciplines. The Clinical Project Risk Manager has experience in implementing risk management on clinical projects aligned with the latest industry regulations and guidance. This person supports evaluation of current processes, and the introduction of new or revised methodologies and/or working practices where needed. The Manager / Sr. Manager supports uniform implementation of any new or revised processes and/or systems at Premier Research through coaching and mentoring to all Premier Research employees involved in the RBQM process. This role supports Executive Management’s strategic vision for implementing a ‘Quality by Design’ approach on Premier Research clinical studies in alignment with overall company goals and objectives.
  • Supports uniform implementation of Premier’s strategic vision for the RBQM methodology.
  • Supports evaluation of the current policies and/or procedures; development and implementation of the new or revised Risk Management policy and supporting systems and tools.
  • Provide input into defining relevant Key Risk Indicators (KRIs) and other metrics to allow evaluation, control and reporting of the potential risks that may hinder the reputation, safety, security and financial prosperity of Premier Research.
  • Delivers training and familiarization of the RBQM methodology, system and tools to the relevant study staff to ensure consistent adherence to the relevant regulations, guidance and our risk policy.
  • Supports implementation of the process strategy for effective project management best practices, procedures, tools and controls related to the uniform implementation of the RBQM process.
  • Supports the collection of KRIs in preparation of quarterly operational reviews with key business leaders and executives, as well as the ongoing risk management on Premier’s projects.
  • Supports improved visibility into organizational RBQM objectives and priorities through information sharing, communication, and collaborative working relationships.
  • Supports executive visibility to issues, risks, KRI progress and ensure reports emphasize trending & predictive analysis.
  • Partners with cross functional departments & TA BUs to drive RBQM process implementation and obtain continual feedback to allow ongoing improvements.
  • Supports the development of the Risk Log with assigned projects teams for risk identification, evaluation, and management to standardize the approach across all functional areas at Premier Research.
  • Provides ongoing support to projects teams on risk identification, evaluation, and management to standardize the approach across all functional areas at Premier Research.
  • Provides all aspects of line management supervision to staff, including, but not limited to, performance management (quality, quantity and timeliness of work performed), and guidance on corporate policy, training, and support.
  • Other activities as designated must be available to perform overnight travel, as required.