Senior Clinical Data Manager / Analyst

    • Redwood City, CA

Summary of Major Responsibilities

The Senior Clinical DataManager / Analyst is responsible for ensuring the accurate, complete and timely collection and delivery of assay/genomic and clinical data for analysis, reporting, and presentation.

Essential Duties and Responsibilities

  • Be the Lead Data Manager on complex clinical studies and projects; either independently or by directing others, provide expert BDM functional representation to study teams.
  • Create, configure and maintain novel or complex clinical study databases and related tools including screen design, edit check development, query management, data extraction and data management related reporting.
  • Proficiently program using SAS and SQL, including moderate to complex data step programming, moderate to complex macro programming and moderate to complex data reporting.
  • Actively maintain knowledge and understanding of current team-, department- and corporate-goals and priorities to ensure effective time management and focus. Assist in developing department goals.
  • Have detailed knowledge of and exhibit consistent compliance with established department and company processes, procedures, guidelines, and best practices.
  • As required, train others on complex company processes, procedures, guidelines and best practices.
  • Prepare and maintain complex documentation, as required by established departmental procedures, practices, or project-specific needs. Review documentation of peers to ensure compliance with established standards.
  • Interact with GHI study team members, collaborators, vendors or partners to gather or define complex requirements, plan deliverables and communicate progress and findings.
  • Train clinical site personnel and collaborators on the effective use of study-specific data management tools.
  • Contribute to the ongoing development and improvement of department procedures by being the primary author of complex process documents and by effectively and actively contributing to or leading process discussions.
  • Work closely and effectively in a team-oriented environment with colleagues from Biostatistics, Non-clinical biostatistics, Clinical Operations, Medical, Pathology, and Program Management to ensure Data Management needs and status updates are addressed and well-communicated.
  • Lead teams with well-defined objectives or interactively lead teams to establish objectives.
  • 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.
  • Participate in recruiting and hiring of staff.
  • Mentor or train coworkers; take project-level supervisory responsibilities.
  • Demonstrated excellent oral, written and presentation communication skills.
  • Demonstrated ability to deliver quality results in a timely manner, either independently or by directing others.
  • Demonstrated excellent organization skills and detail orientation.
  • Demonstrated ability to work effectively with coworkers, external (non-GHI) contacts, and excellent negotiation and conflict resolution skills.
  • Demonstrated 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.
  • Ability to work effectively within a cross-functional team-oriented environment; ability to lead teams and interactively establish team objectives.
  • 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.
  • Regular and reliable attendance.

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Qualifications

Minimum Qualifications

  • Bachelor’s degree in life sciences, scientific or other relevant disciplines.
  • Minimum of 8+ years related experience.
  • Demonstrated proficiency with industry data management processes and procedures.
  • Demonstrated ability to work as the lead data manager/analyst on complex to highly complex projects.
  • Demonstrated programming proficiency with SAS, including moderate to complex data step programming, moderate to complex macro programming and moderate to complex data reporting.
  • Demonstrated proficiency with relational databases and programming complex SQL queries.
  • Demonstrated programming skills in other data manipulation and data processing tools and languages such as R and Tableau.
  • Demonstrated proficiency to programmatically combine and manipulate complex electronic data from a variety of sources.
  • Demonstrated proficiency with executing software development lifecycle practices including requirements definition, risk assessment and programming validation.
  • Demonstrated proficiency in an Electronic Data Capture (EDC) system including complex code-level development for edit check programming and dynamic entry screen programming.
  • Demonstrated proficiency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint; and/or Project.

Preferred Qualifications

  • Relevant post-graduate degree.

EEO Disclosure

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Exact Sciences is a diagnostic company that focuses on the early detection and prevention of colorectal cancer.

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