Associate Director, Clinical Data Management
- Redwood City, CA
Summary of Major Responsibilities
The Associate Director, Clinical Data Management is responsible for managing a team of Clinical Data Managers to support the effective collection and management of clinical study data used for reporting, analysis, and presentation. The functional team that this position leads is responsible for utilizing a variety of different data sources, electronic platforms, and environments to handle clinical data acquisition, data cleaning, data processing, data transfer, and data archival. This role is responsible for ensuring efficient and effective Clinical Data Management deliverables through compliance of established procedures and best practices. The Associate Director, Clinical Data Management performs hands-on data management in support of the collection, mining, and purveyance of clinical, pathology, laboratory, and genomic data in compliance with applicable regulatory requirements.
Essential Duties and Responsibilities
- Assess and recommend functional headcount requirements associated with recruiting and hiring decisions and onboard newly hired staff.
- Evaluate, update, and maintain job descriptions and associated job leveling in alignment with industry benchmarks, relevant salary surveys, and corporate policies and practices.
- Drive the definition and implementation of best practices and standardization to ensure the effective and efficient collection, maintenance and/or handling of laboratory, pathology, and clinical data for Exact Sciences’ studies.
- Provide key input to the definition and utilization of data management systems, tools, processes, and procedures to support successful study execution and results delivery.
- Provide hands-on data management support, as appropriate; including acting as a Lead Clinical Data Programmer/Analyst on the group’s most complex clinical studies and projects.
- Ensure the accurate, complete, and timely collection, validation, and delivery of laboratory, pathology, and clinical data, and related documentation of the highest quality and in accordance with business requirements, timelines, and appropriate budget control based on corporate priorities and objectives.
- Collaborate with functional areas across the company in the strategic evaluation and assessment of data management needs, solutions, and business development opportunities.
- Contribute to the ongoing development and improvement of department procedures by being primary author of highly complex process documents and by effectively and actively leading or contributing to complex process discussions.
- Work closely and effectively in a team-oriented environment with colleagues from Biostatistics, Non-clinical biostatistics, Clinical Operations, Medical, Pathology, Research and Development, and Program Management to ensure Data Management needs and status updates are addressed and well-communicated.
- Lead Data Management teams and cross-functional teams with well-defined objectives or interactively guides these teams to establish objectives.
- Provide 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.
- Manage staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
- Communicate goals clearly to employees to ensure understanding and success in achieving them.
- Motivate and inspire employees to do their best work through coaching.
- Maintain morale and support employee engagement initiatives.
- 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.
- 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 and means to travel between Redwood City locations.
- Ability to travel to other Exact Sciences locations up to 4 times per year.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
- Bachelor’s degree in Life Sciences, Computer Sciences, Scientific, or related field.
- 12+ years of experience in Data Management or related field.
- 5+ years of experience leading or directing people and/or project teams.
- Proficient in Microsoft Office to include Excel macros and pivot tables and Word mail merge.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Master’s degree in Life Sciences, Computer Science, Scientific, or related field.
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.
Back to top