Associate Clinical Affairs Specimen Operations Manager

Exact Sciences • Madison, WI

1d • $64,000 - $105,000 • Remote

About The Position

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Senior Project Coordinator, Clinical Affairs Specimen Operations (CASO) works with product core teams, working groups, clinical study managers, cross-functional support teams, and key stakeholders to ensure that product and clinical goals are met through excellent coordination and communications. This role is responsible for operational and sample management processes; including, but not limited to, all technical, system, and data management components that support the execution of clinical and regulatory affairs work. This position may be remote.

Requirements

• Bachelor’s degree in Business Administration, Engineering, Biology, or other field related to the essential duties of the position.
• 2+ years of work experience in a project-focused environment.
• Proficient with Microsoft Office suite programs.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Applicants must be currently authorized to work in country where work will be performed on a full time or part-time basis.
• We are unable to sponsor or take over sponsorship of employment visas at this time.

Nice To Haves

• Certified Associate in Project Management (CAPM) through the Project Management Institute (PMI).
• Experience with workflow design; including, but not limited to, experience with Visio and/or other related programs.
• Strong understanding of Food and Drug Administration (FDA) regulations and the International Conference on Harmonisation - Good Clinical Practice (ICH GCP); including strong understanding of global regulations.
• Good understanding of clinical systems functionality and requirements.

Responsibilities

• Assist teams to divide and organize work into manageable packages and an actionable schedule.
• Visualize and document processes.
• Assign tasks and confirm completion.
• Ensure on-time delivery of all assigned goals.
• Lead defined small and medium-sized teams and components of large projects and programs.
• Schedule meetings and prepare agenda and minutes at the direction of stakeholders and leads.
• Liaise between internal and external stakeholders and Exact Sciences team members.
• Keep relevant information organized and available to appropriate stakeholders and team members.
• Manage issues and action items; collaborate directly with team members to ensure completion.
• Coordinate and provide communication updates to key stakeholders, management, and team members.
• Maintain positive working relationships with various internal parties and stakeholders.
• Lead and support process improvement initiatives within the clinical and regulatory affairs department.
• Analyze systems user needs to identify efficiencies and gaps; assess cross-functional impact and integrate stakeholder recommendations and needs to streamline process flow.
• Communicate both efficiencies and gaps cross-functionally.
• Manage multiple priorities for various stakeholders in a cross-functional matrix environment.
• Apply strong attention to detail.
• Apply strong verbal and written communication skills.
• Apply effective presentation skills.
• Apply strong analytical, problem solving, and decision-making skills.
• Ability to adapt to rapid changes in priorities, strong sense of urgency, and ability to identify ways to work together to achieve results needed for all requests.
• Ability to organize, present, and convey problems or issues.
• Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
• 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 work designated schedule.
• Ability to work nights and/or weekends, as needed.
• 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 comply with any applicable personal protective equipment requirements.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability and means to travel between Madison locations.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Benefits

• Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level