- Genomic Health, Inc. (GHI) is seeking an exceptional individual with strong leadership, managerial, organizational and technical skills to head its Data Management function.
- The Director, Data Management manages the analytical and clinical data management staff, establishes infrastructure standards, operating procedures and best practices within a developing industry.
- This individual also performs hands-on data management in support of state-of-the-art collection, mining and purveyance of clinical, pathology, laboratory and high-dimensional genomic data in compliance with applicable regulatory requirements.
- The Director, Data Management reports directly to the Senior Director, Medical Operations and Data Management, and is a member of the Biostatistics senior management team.
- Responsible for analytical and clinical data management functional support to Research and Development studies conducted by or with GHI.
- Ensures 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.
- Collaborates with functional areas across the company in the strategic evaluation and assessment of data management needs, solutions and business development opportunities.
- Has direct management responsibility for analytical and clinical data management staff, including but not limited to goal setting, professional development, mentoring, training, performance assessments and compliance.
- Is accountable for assessing and recommending functional headcount requirements, associated recruiting and hiring decisions, and onboarding of newly hired staff.
- Evaluates, updates and maintains job descriptions and associated job leveling in alignment with industry benchmarks, relevant salary surveys, and corporate policies and practices.
- Responsible for identifying strategic needs in technical knowledge and skillset, and driving the strategic direction for the data management function.
- Drives the definition and implementation of best practices and standardization to ensure the effective and efficient collection, maintenance and management of laboratory, pathology and clinical data for Research and Development studies.
- Drives the definition and utilization of data management systems, tools, processes and procedures, to support successful study execution and results delivery.
- Provides hands-on data management support as appropriate.
- Bachelor's degree in computer science, life sciences, scientific or other relevant discipline
- Post-graduate degree.
- Minimum of 10+ years of directly related experience, including 7+ years as data management functional leader and manager.
- Demonstrated competency with, and ability to develop and successfully deploy data management best practice processes and procedures in an FDA-regulated environment.
- Demonstrated competency in the utilization of Microsoft tools, including but not limited to Word; Excel; PowerPoint; and Project.
- Demonstrated proficiency with relational databases, data management and analysis systems, SQL, SAS and other programming languages.
- Demonstrated excellent oral, written and presentation communication skills.
- Demonstrated ability to drive the delivery of quality results in a timely manner, either independently or by directing other.
- Demonstrated excellent business acumen, organization, negotiation and conflict resolution skills.
- Demonstrated ability to be highly effective and influential in a fast-paced, rapid growth environment.
- Track record of success in managing and leading a data management team and function into new frontiers and domains.
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