Exact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Clinical Data Manager I is responsible for the accurate collection, management, and delivery of assay/genomic and clinical data for analysis, serving as the Lead Data Manager on simple clinical studies and projects.
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
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 10% of working time away from work location, may include overnight/weekend travel
Qualification
Required
Bachelor's degree in Life Sciences, Scientific based field, or related field
2+ years of related experience in data management or related field
Knowledgeable of relational database concepts and operation
Professional experience with Electronic Data Capture (EDC) systems and their operation
Professional experience with industry Data Management processes, procedures, and best practices
Able to use Excel for data filtering and sorting
Proficient in Microsoft Office
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Preferred
Relevant post-graduate degree
Coursework or professional experience with SQL queries and/or SAS data steps
Benefit
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
Exact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring.
