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Data Manager, Clinical & Biomarker Data Management

Company: Loxo Oncology, Inc.
Location: Stamford
Posted on: November 20, 2020

Job Description:

This position is uniquely situated to support the Clinical Data Management (DM) team as well as the Biomarker Operations (BMO) team. Clinical DM responsibilities include managing the data flow and transfers for clinical and biomarker data received or distributed by Loxo Oncology at Lilly. This individual will also work with all study DM teams in the creation, validation and distribution of clinical data review and data reporting listings. This position will work collaboratively with the BMO team to facilitate the data transfers of biomarker data from various labs, and also support diagnostic development data activities This individual will ensure that all operations activities stay within full compliance of Loxo Oncology at Lilly regulatory and legal policies. Roles and Responsibilities of the Position Create, execute and/or distribute data management metrics, listings, and reports, as required. Receive, review the quality, and organize biomarker data and incorporate information into internal or external databases as needed. Develop and update current data transfer specifications by gathering input from biomarker scientists to ensure consistent data transfers. Coordinate data requirements with reference labs to ensure data collection are accurate and formatted appropriately for Data Transfer Specification. Author, manage and track all Data Transfer Specifications for DM and BMO. Perform import QC on all data transfers for DM and BMO. Collaborate with study teams to oversee CRO/service providers for all clinical data transfer and biomarker data needs. Coordinate data transfers with diagnostic development partners as needed. Seek means of improving processes to reduce cycle time, increase accuracy, and decrease work effort. Perform any and all other tasks and activities as requested Required Qualifications and Background Bachelor---s degree in life sciences, math, computer science or related field required. 5 years--- clinical development experience. Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH) Laboratory background and/or working knowledge of commonly tested biomarkers in the oncology setting, with latest and advanced analytical tool and assay experience preferred. Previous LIMS (Laboratory Information Management System) experience and working knowledge of the clinical drug development process. Prior experience with data transfers or management for CDx or diagnostic developments programs in general is a plus Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. Excellent verbal/written communication and interpersonal skills and ability to collaborate effectively with cross-functional teams Proven ability to work both independently and in a team setting Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment. Demonstrated ability to stay abreast of trends and new information in the profession. Demonstrated leadership and project management skills. Good working knowledge of ICH, FDA, and GCP regulations and guidelines. Strong well-rounded technical skills (MS Office; MS Word, Excel, PowerPoint). Additional Preferred Qualifications 5 years prior oncology/hematology experience highly desirable 4 years of Sponsor experience.

Keywords: Loxo Oncology, Inc., Stamford , Data Manager, Clinical & Biomarker Data Management, Healthcare , Stamford, Connecticut

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