Data Manager II, 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 II for the Children’s Oncology Group. This position is located in Monrovia, CA.
The Data Manager II is responsible for managing all aspects of study coordination and data acquisition for a group of COG studies. This entails coordination of data collection from institutional investigators, laboratory researchers and study committee members as well as preparation of ad-hoc reports as needed. The Data Manager II of a COG study will be the primary contact for that study between COG and institutional participants in the study, members of the study committee, the Statistics Department, the Study Development Office (SDO), other COG administrative offices, the Information Technology (IT) Department, and the clinical, laboratory, and resource center staff responsible for performing COG studies. The Data Manager II position is one of greater responsibility in terms of work volume, especially understanding the nuances of all applications that are used in day to day activities as well as the possibility of communicating with outside personnel via presentations at annual Group meetings.
Duties & Responsibilities:
The responsibilities of the Data Manager II include, but are not limited to:
- Maintain a larger study volume than a RC I for studies in development and those which are on-going.
- Participate in presentations/discussions regarding a disease area of interest for the CRA discipline committee at COG annual Group meetings.
- Must be fully proficient with all RC related applications (i.e. Study Manager, SDE, RDMS, AQT, etc.).
- 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.
- 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.
- Based on finalized CRFs, implement data elements and data validations through EDC applications (Rave and eRDES). Complete testing, refinement, documentation and release of these screens adhering strictly to the established development procedures.
- Curate and build forms in Form Builder, under the guidelines of caDSR.
- 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.
- Monitor the quality of submitted research data through the eRDES and 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.
- Communicate with institutional sites to resolve queries and data management issues.
- 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.
- Organize, coordinate, or monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol.
- Work with IT staff to address technical problems or system enhancements affecting data systems.
- Expected to work with minimal supervision for the majority of their routine responsibilities.
- Bachelor’s degree or higher in a science-related field or equivalent relevant experience.
- Certification as a Clinical Data Manager (CDM) is preferred. CCDM or other reputable industry certification for clinical data management.
- Minimum three to four years of experience; two to three years of experience as a CRA, CDM and must be a Level I RC for at least 2 yearsExperience as a CRA/CDM in a comprehensive cancer center, cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
- RAVE Curation and Form Builder experience highly preferable.
- High level of basic scripting (SQL) and/or familiarity with data reporting tools desirable.
- High level of PC literacy is required, including intermediate to advanced knowledge of Microsoft Office software such as MS Word, Excel and Access.
- Excellent written and oral communication skills are essential.
- 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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