Project Quality and Risk Management Specialist

7 giorni fa

Roma, Lazio, Italia PAREXEL A tempo pieno
Join Our Team as a Project Quality and Risk Manager

Parexel is a leading global biopharmaceutical services company that provides a comprehensive range of solutions to help clients accelerate the development and delivery of innovative new treatments to patients worldwide. We are currently seeking an experienced Project Quality and Risk Manager to join our team.

About the Role

The Project Quality and Risk Manager will be responsible for ensuring the quality and integrity of clinical trials, as well as identifying and mitigating risks associated with these trials. This role will involve working closely with cross-functional teams, including project managers, clinical research associates, and quality assurance specialists, to ensure that all aspects of the trial are conducted in accordance with regulatory requirements and company standards.

Key Responsibilities
  • Develop and implement quality management plans to ensure the integrity of clinical trials
  • Identify and mitigate risks associated with clinical trials, including those related to data quality, regulatory compliance, and patient safety
  • Collaborate with cross-functional teams to ensure that all aspects of the trial are conducted in accordance with regulatory requirements and company standards
  • Provide quality expertise to support operations, leadership, and clients, enabling the safeguarding and maintenance of patient safety, data integrity, and regulatory compliance
  • Act as a Risk Manager, responsible for coordinating Critical to Quality (CtQ) identification, risk identification, evaluation, and controls
Requirements
  • Excellent communication skills, including verbal and written communication, active listening, providing constructive feedback, and facilitating group discussions
  • Strong interpersonal skills, able to develop relationships and partnerships, build rapport, persuade and influence teams, motivate others, manage performance, and develop talent
  • Expert project manager with strong organizational and planning skills, and competency in risk management with thoughtful action planning
  • Personal awareness and emotionally intelligent, ability to self-motivate, innovate, delegate, and manage time as well as taking ownership and accountability for deliverables
  • Robust skills in interpreting, synthesizing, inferring, evaluating, and extracting pertinent data to identify areas of risk, trends, and aggregated issues
  • Highly adaptable to changing environments, able to think quickly, able to deal with ambiguity, and learn new tasks applying routine knowledge
  • Quality-oriented with an attention to detail, taking initiative, ownership, and accountability for deliverables
  • Expertise to manage the complexity of a matrix environment while valuing the importance of teamwork
  • Ability to travel 10%- 15%
Education and Experience
  • Demonstrated experience in Quality or Risk Management activities
  • Expertise in root cause methodologies (e.g. 5-whys, fishbone diagram, etc.) and CAPA development
  • Expertise in Clinical Trial Risk Management
  • Expertise with ICH-GCP principles
  • English proficiency (written and oral)
  • Bachelor's Degree or other relevant experience required. Life science or other health-related discipline preferred.

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