Clinical Affairs System Specialist II

Help us change lives

At Exact Sciences, we're helpingchange 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 Clinical Affairs System Specialist II is responsible for technical, systems, and process related projects that support the execution of clinical trials. This role will coordinate with all members of the Clinical Affairs team and internal and external stakeholders to successfully execute the clinical study goals of the company. The Clinical Affairs System Specialist II is responsible for providing end user software support to ensure long-term solutions in a growing world-class service environment.

Essential Duties

Include but are not limited to the following:

• Serve as Clinical Affairs primary contact for systems administrative tasks.

• Ability to troubleshoot system issues and investigate problems and incidents as they arise.

• Draft system user guides and train Clinical Affairs staff on system functionality.

• Work with end-users to troubleshoot technical problems.

• Lead system requirement development and systems improvement.

• Analyze systems user needs to identify efficiencies/gaps.

• Assess cross-functional impact and integrate stakeholder recommendations/needs to streamline process flow.

• Act as Subject Matter Expert for legacy systems during system harmonization resulting from mergers/acquisitions.

• Lead metric/data-driven projects.

• Interface with vendors, internal cross-functional teams and clinical sites and articulate technical requirements as required.

• Identify and report problems with systems and/or processes, investigate alternatives, and make recommendations for resolution and improvements.

• Represent Exact Sciences as a customer advocate/liaison both internally and externally.

• Responsible for completing assigned tasks to support study timelines and metrics with minimal direction/oversight.

• Must be able to work both independently and collaboratively as part of the clinical study team to meet study objectives and timelines.

• Lead process improvement initiatives within Clinical Affairs.

• Maintain a working understanding of current SOPs, work instructions, applicable regulations and guidance documents.

• Author Clinical Affairs reference documents, SOPs, and work instructions, as needed.

• Uphold company mission and values through accountability, innovation, integrity,qualityand teamwork.

• Support and comply with the company's Quality Management System policies and procedures.

• Ability to act with an inclusion mindset and model these behaviors for the organization.

• Regular and reliable attendance.

• Ability tolift upto10pounds for approximately5% 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 travel approximately5% of working time.

Minimum Qualifications

• Bachelor's Degree in Health/Life Sciences, Computer Sciences, Information Systems, or a related field as outlined in the essential duties; or Associate's Degree in Health/Life Sciences, Computer Sciences, Information Systems, or a related field as outlined in the essential duties and 2 years of relevant experience working in a related field as outlined in the essential duties; or High School Diploma/General Education Degree and 4 years of relevant experience working in a related field as outlined in the essential duties.

• 2+ years of experience supporting end users of software systems such as Veeva Vault, SampleMinded, ServiceNow, Sharepoint Platforms, Coupa, and/or Planview.

• 2+ years of experience working in a support capacity, supporting end users and IT infrastructure systems.

• 2 + years of Project Management experience, including system rollouts and harmonization efforts.

• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• Authorization to work in the United States without sponsorship.

• Thorough knowledge of applicable clinical research principles and requirements, including FDA Code of Federal Regulations (FDA CFR) and International Council for Harmonisation (ICH), Guideline for Good Clinical Practices (GCP).

Salary Range:

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.

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.

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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.

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