Central Risk Manager

작업 내용

Job Title: Central Risk Manager

Job Location: Taiwan (Homebase acceptable)

Job Overview

The Central Risk Manager (CRM) executes and manages the Risk Based Quality Management (RBQM) process for assigned clinical trials following applicable regulations, standard operating procedures, and work instructions. Range of tasks includes facilitating cross functional teams in protocol risk assessment, assist in developing the integrated data review process, creation of Risk Assessment Management Plan, and tracking of actions taken to investigate or mitigate risk. The Central Risk Manager reports to the Director, Central Monitoring & Surveillance.

Job Duties And Responsibilities

• Facilitate the cross functional study team review of RBQM process to identify critical data and processes on study protocols.
• Generate a Risk Assessment Management Plan (RAMP) to document study risk and integrated data review process in collaboration with the study team members.
• Consult with study team members on inclusion of risk management in functional plans.
• Facilitate risk review meetings with cross functional study team members during study conduct, ensuring proper documentation recorded.
• Escalate to study team members on study wide or site-specific risks requiring remedial or preventative actions.
• Maintain relevant project documents and file required documents in the trial master file (TMF).
• Create and maintain relationships with relevant internal departments, study sponsors, and with external CRO vendors, as directed, to ensure management of RBQM process.
• Attend regular team and client meetings, as requested.
• Attend investigator meetings and provide support, as requested.
• Participate in audit activities, as requested.
• Participate and provide content for bid defense presentations, including collaboration with Clinical Operations for study monitoring strategy.
• Review of project data analytics against key risk indicators and quality tolerance limits, as requested.
• Makes recommendations for improvements and contributes to the ongoing development of the Clinipace RBQM Model.
• Manage the RBQM activities in accordance with Clinipace (CP) SOPs and ICH Good Clinical Practice.
• Contribute to the education and knowledge of RBQM processes across the organization.
• Demonstrate adaptability and collaboration.
• Other duties as assigned by Director, Central Monitoring and Surveillance as relevant to the RBQM process at Clinipace.
• May provide work direction to others in Central Monitoring & Surveillance Department.
• May provide work direction to members on a cross functional project team.
  

Supervisory Responsibilities

No supervisory responsibilities.

Job Requirements

• Education
  • Bachelor’s degree or higher, preferably with a data analytic or life science degree
• Experience
  • Minimum of 1 years of experience in Clinical Risk Assessment or relevant experience
  • Minimum of 4 or more years in Clinical Trials experience (e.g., Clinical Operations, Data Management, or other relevant clinical development activities) in the pharmaceutical or CRO industry
• Skills/Competencies
  • Strong written and verbal communication skills including good command of English language.
  • Leadership skills of collaboration, listening, and directing others.
  • Advanced analytical/problem-solving skills/judgement in decision making.
  • Mastery of ability to identify risks and data trends.
  • Demonstrate proficiency in understanding and use of data analytic software.
  • Strong computer skills, including Microsoft Office including proficiency with Excel.
  • Advanced understanding of clinical research operations.
  • Understanding of clinical trial data, including listings and summary metrics.
  • High level of competency in exercising judgment within defined procedures and practices and to determine appropriate action independently.
  • Familiarity with Electronic Data Capture systems.
  • Able to work without direct supervision.
  • Ability to delivery results on time.
  • Ability to manage competing priorities.
  • Ability to work across cultures and geographies with understanding of cultural differences.
  • Strong interpersonal skills.
  • Comprehensive knowledge of GCP/ICH guidelines.
• Capabilities
  • Ability to work remotely.
  • Travel not required, with the possibility of meeting attendance, as requested.
    
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  The company will not accept unsolicited resumes from third party vendors.