Clinical Affairs Specimen Operations Manager Job at Exact Sciences (Madison)

Job Description

The Clinical Affairs Specimen Operations Manager (CASO) 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 Project Manager, CASO 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.

Job Responsibility

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

Requirements

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 or experience in a project management support role
Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time
Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Nice to have

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

What we offer

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
a retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage
bonus eligible

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Clinical Affairs Specimen Operations Manager

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