Contract - Development Risk Manager

Location
San Francisco, CA, United States
Posted
Feb 10, 2021
Ref
955
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

CONTRACT - DEVELOPMENT RISK MANAGER

Position Summary:

This Program Manager will be accountable for proactively identifying and assessing compliance risks. They will create a portfolio of projects and work closely with the Director of Clinical Operations Excellence to manage through to completion. They will also proactively monitor emerging regulations and policies and ensure GBT proactively monitors and mitigates risks.

Reporting to the Director, Clinical Operations Excellence, the Risk Manager will assist in building awareness and understanding of underlying operational and systems risk and mitigation strategies to all relevant stakeholders and decision makers within Development particularly compliance risks.

Essential Duties and Responsibilities:

 

 

  • Lead Risk Assessments and Management discussion and activities related to Study Execution Teams, Development Working Groups and GxP eSystems
  • Support risk management portfolio of open projects coming from audit and risk assessment activities, including risk management
  • Manage the escalation and resolution of risk and compliance issues including business, security, privacy, compliance and GxP Systems solutions
  • Co-developing, collecting and analyzing, risk management data for transparent reporting of risk measures
  • Support development and update of data integrity policies and procedures
  • Support cross functional teams with identification and planning for vendor solutions for managing data integrity
  • Develop Risk Matrix and propose platform solutions
  • Inform Clinical Operations leaders on the latest regulatory and policy changes that may impact their functions

 


Qualifications:

 

 

 

 

  • Bachelor of Science, or equivalent work experience in Life Sciences or Information Technology
  • While a computer science technical degree is not required, familiarity with technology and the use of IT solutions in business is desired
  • Ability to quickly ramp up knowledge of business and quality management systems
  • Effective collaboration skills - balancing transparency with discretion to key stakeholders
  • Working knowledge of ICH GCP compliance, clinical trial critical process, data and identification, evaluation, control, communication (escalation), review and reporting
  • Strong business acumen and drive to achieve results
  • Strategic thinking by proactively anticipating changing policies and regulations and staying abreast of relevant trends and industry changes
  • Data and reporting savviness to create and manage dashboards and insightful metrics
  • The candidate should be quick to learn from others and build trust while developing deep expertise
  • Organized, detail-oriented, able to perform tasks methodically, and can employ critical thinking in problem-solving
  • Ability to manage multiple simultaneous projects with attention to detail and delivery dates
  • Able to escalate risk with the necessary urgency
  • Strong interpersonal skills with the ability to clearly communicate in writing and verbally