Job Description

Join to apply for the Clinical Data Manager role at Katalyst CRO 3 months ago Be among the first 25 applicants Join to apply for the Clinical Data Manager role at Katalyst CRO To support our expansion efforts, we are looking to add to our team a person that is experienced in clinical abstraction and large project operations. The role will require wearing many hats and Tempus is looking for an individual that is able to coordinate, grow and maintain the abstraction effort, ensuring abstraction processes are run efficiently and data is captured at the highest quality level while meeting project expectations. As a Clinical Data Project Manager (CPM), you will be responsible for managing the data abstraction team that supports the clinical data abstraction for the Studies pipeline. Abstractors review clinical records and structure key data elements into an electronic data capture (EDC) system in alignment with Tempus abstraction rules. The CPM will be responsible for clearly articulating project updates to key stakeholders and collaborate with the Studies team to support transparency and process improvement. You will work closely with the Clinical Studies Manager. Answer escalated cases-specific inquiries that requires clinical expertise/knowledge and ability to apply said knowledge to proprietary data abstraction guidelines. Assist and oversee training of new abstractors and quality analysts on established and/or new cancer subtypes in conjunction with Studies Data Management team. Maintain abstraction quality by developing, interpreting and tracking standards for accuracy of data and implementing corrective action plans as necessary. Ensure data capture is in alignment with Tempus abstraction standards and rules. Act as a conduit between the abstractors and the Studies team, surfacing RWD related issues as they relate to the active cohorts and available information. Liaise with the McCoy Core Clinical team when necessary to keep them abreast of deviations from standard McCoy practices, as well as potential new data points that may be of interest for future McCoy related projects. Stay on top of all due dates and keep active communication to ensure that projects are kept on time or that timelines are revised to appropriately reflect necessary time to completion. Collaborate with the project-specific study team to review specific data elements post case submission to ensure accuracy and completeness. Responsibilities To support our expansion efforts, we are looking to add to our team a person that is experienced in clinical abstraction and large project operations. The role will require wearing many hats and Tempus is looking for an individual that is able to coordinate, grow and maintain the abstraction effort, ensuring abstraction processes are run efficiently and data is captured at the highest quality level while meeting project expectations. As a Clinical Data Project Manager (CPM), you will be responsible for managing the data abstraction team that supports the clinical data abstraction for the Studies pipeline. Abstractors review clinical records and structure key data elements into an electronic data capture (EDC) system in alignment with Tempus abstraction rules. The CPM will be responsible for clearly articulating project updates to key stakeholders and collaborate with the Studies team to support transparency and process improvement. You will work closely with the Clinical Studies Manager. Answer escalated cases-specific inquiries that requires clinical expertise/knowledge and ability to apply said knowledge to proprietary data abstraction guidelines. Assist and oversee training of new abstractors and quality analysts on established and/or new cancer subtypes in conjunction with Studies Data Management team. Maintain abstraction quality by developing, interpreting and tracking standards for accuracy of data and implementing corrective action plans as necessary. Ensure data capture is in alignment with Tempus abstraction standards and rules. Act as a conduit between the abstractors and the Studies team, surfacing RWD related issues as they relate to the active cohorts and available information. Liaise with the McCoy Core Clinical team when necessary to keep them abreast of deviations from standard McCoy practices, as well as potential new data points that may be of interest for future McCoy related projects. Stay on top of all due dates and keep active communication to ensure that projects are kept on time or that timelines are revised to appropriately reflect necessary time to completion. Collaborate with the project-specific study team to review specific data elements post case submission to ensure accuracy and completeness. Requirements: This is an ideal position for someone with both a scientific / clinical and a project management background who is interested in working at the crossroads of healthcare technology and data analysis to solve some of today's most challenging medical questions. 2+ years project management experience. Experience in data entry and/or study builds in Medrio or other EDC systems is necessary. High comfort level working across multiple therapeutic areas and/or cancer subtypes. Knowledge of medical and genomic terminology, medical abbreviations and pharmacy terms and familiarity with medical documentation/EMR document structure. Experience in a fast-paced environment. Excellent interpersonal, written and verbal communication skills. Proficient in Google Suite (Gmail, Google Docs, Sheets, etc.). Strong leadership skills, ability and willingness to work in an agile and expanding team environment. Willingness to be flexible and adapt quickly. 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