Clinical Data Manager I

Help us change lives

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 Clinical Data Manager I is responsible for ensuring the accurate, complete, and timely collection, management, and delivery of assay/genomic and clinical data for analysis, reporting, and presentation. The Clinical Data Manager I acts as Lead Data Manager on simple clinical studies and projects and provides Clinical Data Management functional representation to study teams.

Remote work option available.

Essential Duties

Include, but are not limited to, the following:

• Specify, configure, and maintain clinical study databases and related tools including screen design, edit check development, query management, data extraction, and data management related reporting.
• Maintain knowledge and understanding of current team, department, and corporate goals and priorities to ensure effective time management and focus.
• Provide input, as requested, to assist in the development of department and functional team goals.
• Assist in defining requirements and documenting software development lifecycle activities.
• Exhibit consistent compliance with established departments and company processes, procedures, guidelines, and best practices.
• Train others on basic company processes, procedures, guidelines, and best practices, as required.
• Prepare and maintain basic data management documentation, as required by established departmental procedures, practices, or project-specific needs.
• Review basic data management documentation of peers to ensure compliance with established standards.
• Interact with Exact Sciences study team members, collaborators, vendors, or partners to gather or define basic requirements, plan deliverables, and communicate progress and findings.
• Train clinical site personnel and collaborators on the effective use of basic study-specific data management tools.
• Contribute to the ongoing development and improvement of department procedures by effectively and actively contributing to process discussions.
• Lead Clinical Data Operations (CDO) teams with well-defined objectives on assigned initiatives and special projects.
• Provide appropriate support and coordinate with other functional areas regarding overall clinical study conduct and management, including protocol development, study start-up, study closeout, and data analysis.
• Utilize knowledge of industry data management processes and procedures to effectively contribute to or lead basic data management projects and assignments.
• Create specifications and work closely with Clinical Data Programming to build Electronic Data Capture (EDC) study databases including edit checks and dynamic entry screens.
• Assemble requirements from study teams to develop basic entry forms in EDC systems. Maintain EDC forms during study lifecycle.
• Assist in the planning and execution of User Acceptance Testing (UAT) for assigned EDC study databases. Perform all documentation activities as specified by company and department procedures.
• Mentor coworkers as requested.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Excellent oral, written, and presentation communication skills.
• Excellent organization skills and detail orientation.
• Ability to work closely and effectively in a team-oriented environment with colleagues from Clinical Biostatistics, Non-Clinical Biostatistics, Clinical Affairs, Regulatory Affairs, Medical, Pathology, and Program Management to ensure Clinical Data Management’s needs and status updates are addressed and well-communicated.
• Ability to deliver quality results in a timely manner, either independently or by assisting others.
• Ability to work effectively with coworkers and external contacts.
• Exercise excellent negotiation and conflict resolution skills.
• Ability to be highly effective in a fast-paced, rapid growth environment.
• Ability to receive and apply feedback in a professional manner; ability to convey both positive and constructive feedback to others in a professional and effective manner.
• 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 lift up to 10 pounds for approximately 5% of a typical working day.
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