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At Quest, we are on a continuous journey of discovery and development. It’s this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.
As a Clinical Development Data Manager, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing.
Clinical Development Data Manager – the role:
The Clinical Development Data Manager is responsible for managing clinical, sample repository and portfolio data, database and software tools development and maintenance activities. This professional will work with medical, scientific and clinical development leadership, clinical correlations, portfolio and development project management and other stakeholders to define need and requirements for data management across the organization.
Reporting to the Director of Bioinformatics, the Clinical Development Data Manager will also interact with stakeholders in other business units and functions involved in the portfolio and clinical research activities, external clinical research organizations as well as other academic institutions to ensure deliverables are met.
- Development and maintenance of a database, query tools, and Graphical User Interface (GUI) for our Sample Repository in conjunction with S&I and the Bioinformatics group and communicate and train the scientific users on how to submit and manage project and use the sample repository
- Manage the database of ongoing studies, planned studies and sample needs across R & D. Help discover, clarify and enable prioritization of sample needs. Work with Portfolio management to coordinate projects with external contract research organizations and academic institutions.
- Work to centralize bioinformatics and data management projects and manage with the bioinformatics team. Manage individual projects with analysts, advisors and scientific owners.
- Support further development of enterprise wide project management tool to manage R & D documentation and projects
- Develop in-house clinical data management plan by working with S&I management to create vision, assess needs, define scope, and perform resource versus outsource analysis to plan data management capabilities and direction
- Collaborate effectively with cross-functional management committees and external partners.
- Develop the portfolio database, query and reporting tools and develop communications strategies to ensure information is useful across the company to drive R & D projects
- Provide timely and accurate information to Portfolio Management for program level tracking.
To qualify, the ideal candidate will have the following skills and experience:
- 5+ years of diagnostic clinical data management experience, preferably in multiple therapeutic areas
- 3+ years of hands-on experience with managing data repositories, biological sample and clinical data banking databases and software, statistical software programs, and/or project management tracking software
- Good communications skills and demonstrated ability to assess needs from business owners and develop data management solutions to address
- Knowledge of Good Clinical Practices (GCP’s) and International Conference on Harmonization (ICH) guidelines; Clinical Laboratory Improvement Amendments (CLIA), ISO 9001 knowledge helpful
- BS degree or related experience; advanced degree preferred
- Ability to travel as required
Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.
Your Quest career. Seek it out.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity/Citizenship.