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Associate Director, Study Operations #2846

Grail

Grail

Operations
Menlo Park, CA, USA
Posted on Thursday, April 6, 2023
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
As an Associate Director, Study Management, you will play a critical role in leading a global team that will manage the testing of clinical trial samples within our laboratory. You will be strong in leading a team that manages multiple trials simultaneously. You are a collaborative leader and you demonstrate a strong track record of success in a cross­-functional team environment guiding development of complex workflows and processes to meet business goals.

You Will;

  • 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.

Your qualification and background will include:

  • 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
The expected, full-time, annual base pay scale for this position is $154,000 - $205,000. Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.