Associate Director
Study Operations
Posted on 4/4/2023
INACTIVE
GRAIL

1,001-5,000 employees

Designs cancer screening tests
Company Overview
GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
Data & Analytics

Company Stage

N/A

Total Funding

$11B

Founded

2016

Headquarters

Menlo Park, California

Growth & Insights
Headcount

6 month growth

4%

1 year growth

9%

2 year growth

23%
Locations
Menlo Park, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Requirements
  • BA/BS with 10 years of experience, or Masters with 7 years of experience in Clinical Trial Management
  • A minimum of 3 years prior experience leading a global team
  • Experience with Clinical Trial Laboratory testing highly desirable
  • Ability to effectively manage multiple competing priorities and negotiate scope, requirements, and specifications across the organization
  • Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA, GDPR, MHRA
  • Ability to work as part of a team within a highly collaborative environment
  • Ability to communicate effectively in verbal, writing, and presentations and meet deadlines
Responsibilities
  • Develop and implement the processes for the Study Management function to collaborate with CROs, Pharma partners and internal stakeholders for the operational planning and execution of clinical trials
  • Develop a comprehensive study management lifecycle that spans from requirements gathering through lab execution planning and return of data and specimens
  • Develop and implement a standardized process for capturing study requirements from internal and external stakeholders. This will involve working closely with cross-functional teams, including the Principal Investigator, Clinical Operations, CROs, participating sites, Medical Affairs, and Lab Operations, to ensure that all study requirements are accurately documented and communicated in a timely manner
  • Align study requirements with overall study objectives and ensure that all study-related processes and procedures are well-documented and consistently applied across all studies
  • Support the execution of clinical trials by leading study program status meetings, working with internal and external stakeholders to ensure that studies remain on track throughout the study lifecycle, Serve as the primary point of contact for all internal and external teams for all clinical studies. Ensure that a point of contact from the study management team is assigned to each clinical study as a primary operational point of contact
  • Be responsible for managing team members work allocation, ensuring that each team member is trained in the common set of study management tasks, and that the study management workload is evenly distributed across team members
  • Provide expert technical guidance to team members for the effective execution of Study Management functional activities, including overseeing , planning and management of study-related activities to ensure successful completion of clinical trials and strategic planning
  • Use professional and industry concepts in accordance with company objectives to contribute to the development of processes to solve complex problems (e.g. develop sample workflows, reconciliation plans, study management plans, vendor management plans, etc) in creative and effective ways that are scalable and reproducible
  • Provide expertise and oversight in the areas of clinical principles, applicable laws, regulations and guidelines that promote the highest level of bio-specimen data quality, and support adherence to ethical and legal requirements, including but not limited to ICH, GCP and GLP
  • Implement project management principles and concepts in study management including identification and management of project scope, defining and tracing requirements, creating project plans and managing timelines with various dependencies
  • Work on problems of diverse scope (i.e. sample reconciliation) where analysis of situations or data requires evaluation of identifiable factors
  • Exercise independent decision making that impacts study operations and overall study conduct. This will include analyzing data, identifying trends and making recommendations on process improvements or protocol changes
  • Foster strong partnerships with internal and external cross-functional teams to promote an open, collaborative and productive working environment
  • Actively engage with team members to identify areas to improve efficiency or overcome obstacles
  • Interact with external collaborators to develop workflows for the transfer and disposition of samples, while also developing related documentation (i.e. MTAs, BMPs, etc) independently and in a timely manner
  • Develop and foster strong external partnerships to support the successful execution of clinical studies. May act as study representative on large-scale clinical studies involving multiple external collaborators