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Lead Clinical Data Manager

2 weeks ago

Redwood City, California, United States Exact Sciences Full time $136,000 - $231,250 per year

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 Lead Clinical Data Manager 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 Lead Clinical Data Manager acts as Lead Data Manager on highly complex clinical studies and projects either independently or by directing others, providing expert Clinical Data Management functional representation to study teams.

Remote work option available.

Essential Duties
Include, but are not limited to, the following:

  • Independently specify, configure, and maintain highly complex 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.
  • Assist in developing department and functional team goals.
  • Lead requirements gathering and documentation of software development lifecycle activities.
  • Exhibit consistent compliance with established department and company processes, procedures, guidelines, and best practices.
  • Train others on highly complex company processes, procedures, guidelines, and best practices as required.
  • Prepare and maintain highly complex data management documentation, as required by established departmental procedures, practices, or project-specific needs.
  • Review highly complex 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 highly complex requirements, plan deliverables, and communicate progress and findings.
  • Train clinical site personnel and collaborators on the effective use of highly complex study-specific data management tools.
  • Contribute to the ongoing development and improvement of department procedures by being the primary author of highly complex process documents and by effectively and actively contributing to or leading process discussions.
  • Lead Clinical Data Operations (CDO) teams or cross-functional teams with well-defined objectives or interactively lead teams to establish objectives on assigned initiatives and special projects. As needed, directly manage staff.
  • 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 expert knowledge of industry data management processes and procedures to effectively lead highly complex data management projects and assignments.
  • Create specifications and work closely with Clinical Data Programming to build highly complex Electronic Data Capture (EDC) study databases including edit checks and dynamic entry screens.
  • Assemble requirements from study teams to develop highly complex entry forms in EDC systems. Maintain EDC forms during study lifecycle.
  • Lead 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.
  • Participate in recruiting and hiring of staff.
  • Mentor coworkers; take project-level supervisory responsibilities for large-scale projects.
  • 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 directing 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.

Minimum Qualifications

  • Master's degree in Life Sciences, Scientific based field, or related field; or Bachelor's degree in Life Sciences, Scientific based field, or related field plus 2 years of related experience in lieu of Master's.
  • 8+ years of related experience in data management or a related field.
  • Expert knowledge of relational database concepts and operation.
  • Professional experience and expert proficiency with Electronic Data Capture (EDC) systems.
  • Professional experience and expert proficiency 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.
  • Legal authorization to work in the country of employment without current or future sponsorship.

Preferred Qualifications

  • Relevant post-graduate degree.
  • Expert knowledge of industry data management processes and best practices.
  • Experience leading the planning and execution of UAT fir EDC databases.
  • Experience mentoring, training and providing feedback for junior level CDM's.
  • Experience leading initiatives to streamline data management quality processes.

Salary Range:

$136, $231,250.00

The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible.

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.

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. The documents summarize important details of the law and provide key points that you have a right to know.