Position Overview
The Clinical Affairs Specimen Operations (CASO) Manager works with cross functional support teams and key stakeholders to support the logistical stand up of all clinical studies and ensure that supply and sample management needs meet the study design requirements. This role will facilitate the project milestone development, facilitate teams to execute and communicate to the broader organization. The CASO Manager supports the clinical study portfolio for Exact Sciences commercial and pipeline products, collaborating with Product Core Teams and their respective working groups to successfully meet the development, evidence generation and overall strategic needs of each Exact Sciences product.
This position is based in our Madison, WI office location.
Essential Duties
Include, but are not limited to, the following:
- Develop operational relationships with cross functional team members including but not limited to Clinical Laboratories, Regulatory Affairs, Research and Development, Program Management, Biorepository and others as appropriate.
- Lead defined small and medium-sized projects and components of large projects/programs.
- Coordinate all activities required for supply and sample management set up for internal and external clinical studies.
- Liaise between internal and external stakeholders and Exact Sciences team members.
- Coordinate and provide communication updates to key stakeholders, management, and team members.
- Lead and support process improvement initiatives within clinical and regulatory affairs.
- Analyze systems user needs to identify and communicate efficiencies/gaps cross-functionally.
- Assess cross-functional impact and integrate stakeholder recommendations/needs to streamline process flow.
- Visualize and document processes.
- Define and report on metrics that are indications of the health of the day-to-day sample and data elements supporting clinical studies.
- Improve the metrics and tracking that feed overall study performance to make decisions on usable samples/subjects, enrollment projections, and advancement of the forecasting process that is required to support study logistics.
- Assist teams with breaking project work into manageable packages and organizing into a project schedule.
- Keep related information organized and available to appropriate stakeholders and team members.
- Manage issues and action items by collaborating directly with team members to ensure completion.
- Maintain positive working relationships with various internal parties and stakeholders.
- Assign tasks and confirm completion.
- Ensure on-time delivery of all assigned goals.
- Schedule meetings and prepare agenda and minutes at the direction of stakeholders and collaborators.
- Strong attention to detail.
- Ability to organize, present, and convey problems or issues.
- Manage multiple priorities for various stakeholders in a cross-functional matrix environment.
- Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.
- Strong verbal and written communication skills.
- Effective presentation skills.
- Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
- Analytical, problem solving and decision-making skills.
- Ability to coordinate multiple tasks both owned individually and by others.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to lift up to 10 pounds for approximately 5% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to work on a computer and phone simultaneously.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability and means to travel between local Exact Sciences locations.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s degree in the health or life sciences, or a field as outlined in the essential duties, or Associate’s degree in the health or life sciences and 2 years of experience in a field as outlined in the essential duties in lieu of Bachelor’s degree, or High School Degree/General Education Diploma and 4 years of experience in a field as outlined in the essential duties in lieu of Bachelor’s degree.
- 5+ years of experience in a Clinical, IT, or Regulatory role, or a field as outlined in the essential duties.
- 3+ years of experience in a project management support role.
- Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
- 2+ years of experience in process and workflow design, and process improvement.
- Certified Associate in Project Management (CAPM) through PMI.
- Strong understanding of FDA regulations and ICH GCP. Understands global regulations. Good understanding of clinical systems functionality and requirements.
