Associate Clinical Affairs Specimen Operations Specialist

JOB DESCRIPTION:

Position Overview

The Associate Clinical Affairs Specimen Operations Specialist 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.

The ideal candidate is a highly organized, detail-oriented professional who thrives in a collaborative team environment and is eager to develop expertise in clinical specimen operations. They demonstrate strong execution skills, accountability, and a commitment to delivering high-quality work while managing multiple priorities.

This individual is proactive in identifying and resolving operational challenges, communicates effectively with stakeholders, and embraces opportunities to learn and grow. They are dependable, adaptable, and motivated to contribute to the successful execution of clinical studies through strong partnership, accuracy, and continuous improvement.

Essential Duties

Include, but are not limited to, the following:

• 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 to travel 10% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• 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.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 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 Harmonization - Good Clinical Practice (ICH GCP); including strong understanding of global regulations.
• Good understanding of clinical systems functionality and requirements.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: