MANAGER/SENIOR MANAGER, REGIONAL MONITORING
MANAGER/SENIOR MANAGER, REGIONAL MONITORING
GRAIL, Inc., is a discovery-stage life sciences company that is developing differentiated platforms for the early detection of cancer. GRAIL’s research programs combine approaches to ultra-deep sequencing of circulating, cell-free nucleic acids with innovative clinical programs of the scale and quality required to generate strong scientific and clinical evidence of their utility. GRAIL’s software and computational biology efforts are commensurate to the size and complexity of the resulting data sets. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.
The Manager/Senior Manager, Regional Monitoring is responsible to develop and drive the quality management system for monitoring across the GRAIL regional monitoring function to proactively assess, manage and mitigate quality risks for the organization in alignment with overall business goals and optimized operational models. This individual will leverage analytics and other approaches to perform trend analysis of monitoring practices and systems and make enhancements as needed, lead regional monitoring strategy and teams to develop strong relationships with GRAIL preferred partners, and lead inspection readiness, root cause analysis and response teams for regional audits and inspection by health authorities for monitoring processes and systems.
TASKS AND RESPONSIBILITIES
- Work in collaboration with the GRAIL Regional Monitoring team and other key stakeholder within GRAIL Clinical Development and Medical Affairs (CDMA), and affiliates to devise and implement the oversight and monitoring strategy and mechanism/systems for GRAIL affiliates that is consistent with the oversight principles and plans for CDMA.
- Focuses on review and continuous improvement of regional monitoring processes GRAIL. Identify opportunities to improve quality, compliance, and efficiency. Lead and initiate regional monitoring teams to leverage staff diversity of experience in implementation of new, more effective ways of working.
- Partners with internal GRAIL groups to develop, delivery and implementation of training for GRAIL Regional Monitors as appropriate. Promotes consistent communication and distribution of information and relevant process changes including updates to training curriculum.
- Partners with senior leadership in monitoring, CDMA and Quality to develop and implement Quality management system for monitoring with a keen focus on creation of metrics, key quality and performance indicators. Analyze metrics and provide insights to regional and global monitoring performance. Lead audit and inspection readiness in the monitoring function and development of root cause analysis and CAPA in response to internal audits and inspection by health authority agencies.
- Leverages analytics to perform trend analysis of monitoring information on in-house and outsourced studies to identify gaps in performance and quality. Evaluates the evolving clinical research operations environment and competitive landscape, generates ideas and recommendations, and participates in quality assurance activities that foster continuous improvement across clinical programs and processes.
- Collaborates with Clinical Operations to develop and manage consistent practice processes, plans, documentation systems and report templates to be utilized across programs and regions.
- Partners with other colleagues in CDMA for administration of SOPs which will facilitate execution & oversight of both in-house and outsourced clinical trials/programs compliant with ICH/GCP standards.
- Leads the implementation of large scale monitoring initiatives that affect the department
- Serves as functional manager for team members in the Senior CRA role.
- BA/BS/MS or advanced degree preferred but not required in other relevant scientific area.
- 10+ year experience in monitoring, monitoring strategy and managing remote, regional monitoring teams
- Experience with direct management of team members within a similar functional role.
- Experience with leading teams in a matrix structure.
- Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience can substitute in part for IVD experience.
- Experience in clinical research and successful clinical trials conduct in genomics, diagnostics, oncology, or other applied medical fields
- Demonstrated ability to work independently with new, complex technologies and produce professional work products.
- Possess excellent organizational, record retention, time management, decision-making, customer service, communication, and interpersonal skills.
- Possess excellent analytical, thorough follow-through, planning, and implementation skills.
- Strong team player with demonstrated track record of success in cross-functional team environment and leadership roles.
- Strong work ethic and demonstrated ability to deliver assignments on time.
- Thrive in a team-oriented and values-driven environment.
- Be flexible and embrace change.
- Ability to travel as required (up to 25%).
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.