Clinical Affairs Specimen Operations Manager

About the role

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.

Responsibilities

• 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.
• Career 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.
• 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.

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 of experience in a project management support role.
• Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.

Qualifications

• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Skills

• Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.
• Strong understanding of FDA regulations and ICH GCP. Understands global regulations.
• Good understanding of clinical systems functionality and requirements.

Benefits

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here. Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub.

Pay

Salary Range: $76,000.00 - $125,000.00 The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.

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. Learn more about our benefits.