Data Manager, Public Health Institute
The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally and internationally. PHI was distinguished as one of the top 50 “Best Non-profit Organizations to Work For” by the Non-Profit Times in a national search.
PHI is seeking a full time regular Data Manager for the Children’s Oncology Group. This position is located in Monrovia, CA.
The Children’s Oncology Group (COG), a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 9,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the United States are cared for at Children’s Oncology Group member institutions. COG’s unparalleled collaborative efforts provide the information and support needed to answer important clinical questions in the fight against cancer. The Children’s Oncology Group has nearly 100 active clinical trials open at any given time. These trials include front-line treatment for many types of childhood cancers, studies aimed at determining the underlying biology of these diseases, and trials involving new and emerging treatments, supportive care, and survivorship.
The Data Manager is responsible for managing all aspects of study coordination and data acquisition and management for COG clinical studies. They serve as the primary study liaison between the Statistics and Data Center at COG and the multiple external and internal entities involved with the study. The Data Manager also coordinates and develops the case report forms (CRFs) prior to study activation. The Data Manager position is one of greater responsibility in terms of work volume, especially understanding the nuances of all the applications that are used in daily activities to manage trials as well as the nuances of the study from a regulatory and scientific perspective.
Duties & Responsibilities:
The responsibilities of the Data Manager include, but are not limited to:
1. Review sections of study protocols related to patient treatment, supportive care, specimen submission, patient follow-up, and any other sections requiring understanding of clinical or laboratory aspects of COG studies.
2. In collaboration with the study statistician and study committee, design the draft Case Report Forms (CRFs) and data validations required to collect the necessary research data for COG studies.
3. Aid in creating new data elements (DEs) as needed to capture essential research data for the study, or identify required DEs from the existing database, following established guidelines and procedures.
4. Based on finalized CRFs, implement data elements and data validations through the Enhanced Remote Data Entry System (eRDES) and/or RAVE applications. Complete testing, refinement, documentation and release of these screens adhering strictly to the established development procedures.
5. Knowledge and use of RAVE curation and Form Builder for eCRF design.
6. Manage the conduct of studies including, but not limited to, monitoring patient enrollments and randomizations and closing or suspending studies as determined by protocol design or Study Chair to ensure patient safety. Create and execute the Study Data Review Plan according to established procedures.
7. Monitor the quality of submitted research data through the eRDES and/or RAVE reporting module to evaluate timeliness of institutional data submissions and the completeness and internal consistency of data. When necessary, modify or enhance data validations to prevent and correct data errors and omissions that have been identified.
8. Set up and monitor systems for rapid tracking and reporting of dose-limiting toxicities, toxic deaths, severe adverse events (SAEs), treatment failures, or other critical study endpoints, as appropriate for the study.
9. Organize, coordinate, or monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol.
10. Work with IT staff to address technical problems or system enhancements affecting data systems.
• Bachelor’s degree or higher in a science-related field or equivalent relevant experience.
• Certification as a Clinical Data Manager (CCDM) preferred but not required.
• Two years experience as a CRA, CDM or equivalent combination of experience and education credits.
• Direct experience as a CRA/CDM in a comprehensive cancer center or cooperative group is preferred but not required.
• Excellent written and oral communication skills are essential.
• High level of PC literacy is required, including intermediate to advanced knowledge of Microsoft Office software such as MS Word, Excel and Access.
• High level of basic scripting (SQL) and familiarity with data reporting tools preferred but not required.
• Must have collaborative and problem-solving skills.
This is a non-exempt position and the hourly wage is commensurate with experience. PHI offers a generous benefits package including medical, dental, vision, short/long term disability insurance, life insurance, 403b (group retirement annuity) and partial subsidy of public transportation cost. For more information about PHI’s benefits, visit our benefits page at https://www.phi.org.
How to apply:
To apply for this position visit our Career Site at https://www.phi.jobs.
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