CrawlJobs Logo

Clinical Affairs Specimen Operations Manager

exactsciences.com Logo

Exact Sciences

Location Icon

Location:
United States , Madison

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

76000.00 - 125000.00 USD / Year
Save Job
Save Icon
Apply Position

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

Additional Information:

Job Posted:
February 18, 2026

Employment Type:
Fulltime
Work Type:
Remote work
Icon
Exact Sciences - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
+ Unlock 31694 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Clinical Affairs Specimen Operations Manager

Senior Clinical Affairs Specimen Operations Manager

The Sr. Clinical Affairs Specimen Operations Manager leads planning and executio...
Location
Location
United States , Madison
Salary
Salary:
91000.00 - 155000.00 USD / Year
exactsciences.com Logo
Exact Sciences
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in health or life sciences, supply chain, engineering, or a related field relevant to specimen logistics or clinical operations
  • 7+ years of experience in clinical trial operations, specimen or sample management, logistics, supply chain, or related operational support of clinical studies
  • Demonstrated experience coordinating cross‑functional activities, applying working knowledge of project management principles to support execution across multiple studies or initiatives
Job Responsibility
Job Responsibility
  • Leads operational planning and strategic management of specimen logistics for assigned clinical studies, ensuring supply, collection, shipment, receipt, processing, storage, and reconciliation meet protocol and regulatory standards
  • Translates study requirements into actionable specimen operations plans, coordinating timelines, deliverables, and execution with clinical, laboratory, program, and external partners
  • Manage and analyze key specimens and supply performance metrics (e.g., kit usage, sample quality, chain of custody, turnaround times) to identify risks, opportunities, and data‑driven improvements supporting reliable study delivery
  • Problem-solves and resolves specimen and logistics issues, applying sound judgment to prioritize actions, escalate when needed, and ensure timely resolution in line with established procedures
  • Lead continuous process improvement, contributing to workflow documentation, standard practices, and initiatives that enhance efficiency, consistency, and scalability across studies
  • Provides guidance, coaching, and knowledge sharing to less‑experienced team members, serving as a resource on specimen operations processes, tools, and best practices within clinical research
  • 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
What we offer
What we offer
  • Paid time off (including days for vacation, holidays, volunteering, and personal time)
  • Paid leave for parents and caregivers
  • Retirement savings plan
  • Wellness support
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Bonus eligibility
  • Fulltime
Read More
Arrow Right

Scientist II, Biology

This position reports to the Senior Staff Scientist within the Biological Scienc...
Location
Location
United States , Franklin Lakes, NJ
Salary
Salary:
30.00 - 35.00 USD / Hour
gomillenniumsoft.com Logo
MillenniumSoft Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. 5+ years experience
  • M.S. 3+ years experience
  • Ph.D. preferred
  • Minimum of a B.S. in Cell/Molecular Biology or related field is required
  • Experience operating a BD LSR Fortessa X-20 flow cytometer required
  • Experience using FACS DIVA software required
  • Experience using FlowJo software required
  • Experience with flow cytometry sample preparation and whole blood staining required
  • Experience with isolation of peripheral blood mononuclear cells required
  • Must be proficient with MS Office
Job Responsibility
Job Responsibility
  • Design and execute experiments using applied biological sciences that further the development, verification, and evidence generation efforts across all assigned programs and projects
  • Execute and drive flow cytometry assay development/validation for regulatory submission studies
  • Maintain laboratory equipment including a BD LSR Fortessa X-20 flow cytometer and other instrumentation used in evaluating coagulation
  • Document and build technical knowledge within assigned business areas
  • explore and recommend solution concepts and principles when applicable
  • Own and drive key product development work streams including but not limited to Requirements Management, Design Verification, and Design Transfer to Manufacturing for applicable assignments
  • Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs, Manufacturing, Quality and Regulatory Affairs
  • Fulltime
Read More
Arrow Right
New

Senior Lecturer/Associate Professor in Literacy

As a Senior Lecturer / Associate Professor in Literacy, you will play a key role...
Location
Location
Australia , Albury-Wodonga, Bathurst, Port Macquarie, Wagga Wagga
Salary
Salary:
Not provided
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 08, 2026
Flip Icon
Requirements
Requirements
  • A doctoral qualification relevant to literacy or education, with a recognised teaching qualification
  • A strong record of high-quality teaching and student-centred learning
  • An established or emerging research profile aligned to literacy, curriculum or pedagogy
  • The ability to build productive partnerships and contribute to academic leadership
Job Responsibility
Job Responsibility
  • Lead impactful literacy teaching and research
  • Teach across online and on-campus environments
  • Shape future teachers and education practice
  • Contribute to curriculum innovation
  • Build strong relationships with students and partners
  • Provide academic leadership in literacy education
  • Contribute to the School's research profile
  • Supervise higher degree research students
  • Actively engage with professional, community and government stakeholders
  • At Associate Professor level: significant academic leadership, research impact, and contribution to the broader discipline at national/international level
What we offer
What we offer
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Program Manager - Controls and Avionics Solutions

This position is based in Endicott, New York. New York and on-site work will be ...
Location
Location
United States , Endicott
Salary
Salary:
120874.00 - 205486.00 USD / Year
baesystems.com Logo
Baesystems
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in engineering, engineering or manufacturing management, or other discipline
  • Demonstrated ability for building strong customer/ stakeholder relationships
  • Strong communication, negotiation, and presentation skills
  • Ability to interpret data and make data-driven decisions
  • Highly adaptable with strong initiative
  • Demonstrated ability to lead and motivate cross-functional teams
  • Knowledge of the global aviation market and regulatory requirements and/ or military aviation market
Job Responsibility
Job Responsibility
  • Maintaining strong customer relationships and leading a multidisciplinary team to execute complex development programs within schedule and budget
  • Leadership and management oversight of a project team assuring that project’s financials, schedule, and technical objectives are met and that the highest level of customer satisfaction is achieved while meeting all contractual commitments
  • Work effectively and collaboratively with Engineering, Operations, and all Program Office functional leadership to assure deliveries continue to exceed customer commitments and achievement of financial commitments to the company
  • Manages, coordinates, plans, organizes, controls, integrates, and executes projects within the Military Aircraft Systems portfolio
  • Participates in the support of new business and in the development of proposals
What we offer
What we offer
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Health savings accounts
  • 401(k) savings plan
  • Disability coverage
  • Life and accident insurance
  • Employee assistance program
  • Legal plan
  • Discounts on home, auto, and pet insurance
  • Fulltime
Read More
Arrow Right
New

Finance Business Partner (Research)

Full Time, Fixed Term (12 months). Level 7 - $101,421 to $110,819 p.a. (plus 17%...
Location
Location
Australia , Wagga Wagga
Salary
Salary:
101421.00 - 110819.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 02, 2026
Flip Icon
Requirements
Requirements
  • A degree in Accounting or Finance (professional accounting body membership is desirable)
  • Experience in project budgeting, forecasting and financial analysis
  • Background in management accounting or business partnering within complex environments
  • exposure to government funding or higher education is advantageous
  • Excellent stakeholder engagement skills, with the ability to work effectively with academics and researchers
  • Familiarity with business intelligence systems and dashboard reporting
Job Responsibility
Job Responsibility
  • Partner with academics to deliver strategic financial insights that enable research success
  • Directly influence world-class projects and decisions shaping the future of education and innovation
  • Lead initiatives that enhance financial governance, deliver accurate and timely reporting, and support key projects such as cost-pricing systems and research budgeting
  • Help build financial capability across the University, fostering collaboration and continuous improvement
What we offer
What we offer
  • Flexibility with a 35-hour work week
  • Access to hybrid work arrangements
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Associate Lecturer/ Lecturer in Oral Health

Make a real impact by educating future oral health professionals to serve the ur...
Location
Location
Australia , Wagga Wagga
Salary
Salary:
80046.00 - 134965.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 16, 2026
Flip Icon
Requirements
Requirements
  • A qualification relevant to the discipline and appropriate to the level being applied for
  • Full registration (for teaching/research) as a Dentist or Oral Health Therapist with the Australian Health Practitioner Regulation Agency (Ahpra)
  • Excellent understanding of the clinical practice of oral health therapy, supported by a record of teaching and subject coordination relevant to the discipline and appropriate to the level being applied for
  • Evidence of the delivery of high quality student-centred learning and teaching in oral health therapy and/or general dentistry
  • A record of research activity or capability relevant to the discipline and appropriate to the level being applied for, as outlined in the position descriptions, may facilitate the progression of research opportunities
Job Responsibility
Job Responsibility
  • deliver high-quality teaching, clinical supervision and learning experiences in Oral Health
  • work with students in both clinical and preclinical settings while contributing to curriculum development, industry engagement and community partnerships
What we offer
What we offer
  • Generous support provided to assist with relocating to Riverina’s beautiful Wagga Wagga or surrounds
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Change Analyst

As Change Analyst you will provide specialist change management expertise to sup...
Location
Location
Australia , Albury-Wodonga, Bathurst, Dubbo, Orange, Wagga Wagga
Salary
Salary:
101421.00 - 110819.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 03, 2026
Flip Icon
Requirements
Requirements
  • Relevant qualifications and/or equivalent experience in organisational change and transformation
  • Experienced in applying change management frameworks and methodologies to large-scale/complex organisational initiatives
  • Skilled in analysing change impacts and shaping clear, targeted responses in policy-driven environments
  • Strong communication and interpersonal skills
Job Responsibility
Job Responsibility
  • Provide specialist change management expertise to support the successful planning and implementation of the Models of Engagement and Assessment initiative
  • Lead change analysis, stakeholder engagement planning and adoption activities to enable a sustainable transition to new models of course delivery and assessment.
What we offer
What we offer
  • Competitive salary and benefits including 17% super
  • Flexible working arrangements that support a healthy work-life balance
  • Fulltime
Read More
Arrow Right
New

Postdoc / Research Fellow in Digital Agricultural Futures

We are seeking a Research Associate / Postdoctoral Research Fellow (Level A) or ...
Location
Location
Australia , Mildura
Salary
Salary:
80046.00 - 134965.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 10, 2026
Flip Icon
Requirements
Requirements
  • Level A: A relevant postgraduate qualification (Masters or PhD) or equivalent experience in digital agriculture, irrigation, spatial science or related fields
  • Level B: A completed PhD (or equivalent standing) with demonstrated independent research capability
  • Experience in applied or multidisciplinary research environments, ideally connected to agriculture, education, or regional systems
  • Knowledge of, or interest in, education and training frameworks, workforce development or professional learning
  • Strong communication and relationship-building skills, with the ability to work effectively with researchers, industry and community stakeholders
  • The ability to manage priorities, work independently and collaboratively, and contribute to impactful research outcomes
Job Responsibility
Job Responsibility
  • Preparing the future workforce for digital irrigated agriculture
  • Working closely with academics, industry partners, education providers and communities across the Murray–Darling Basin
  • Contributing to research that explores digital literacy, education frameworks and innovative delivery models for contemporary agriculture
  • At Level A: contributing to research delivery under the guidance of senior researchers, supporting data collection, analysis, stakeholder engagement and co-authored outputs
  • At Level B: taking a more independent and substantive leadership position, leading defined research components, cultivating partnerships, and producing high-quality scholarly and industry-focused outputs
  • Regular interstate travel is required, along with strong collaboration across multidisciplinary and industry-linked projects
What we offer
What we offer
  • 17% superannuation
  • Relocation opportunity to Mildura, VIC
  • Flexible/hybrid arrangements considered
  • Fulltime
Read More
Arrow Right