Senior Manager, Risk Management

Location
South San Francisco, CA
Posted
May 15, 2022
Ref
4459737004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

SENIOR MANAGER, RISK MANAGEMENT

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 potential GxP eSystems
  • Continuous process improvement of GBT Risk Tool for organizational maturity
  • Co-developing, collecting and analyzing, risk management data for transparent reporting of risk measures
  • 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
  • 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
  • Inform Clinical Operations leaders on the latest regulatory and policy changes that may impact their functions

Qualifications:

  • 6-9+ years of relevant experience and bachelor’s degree, or equivalent work experience in Life Sciences or Information Technology.  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

Fit with GBT culture

  • Integrity
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.