StamfordRecruiter Since 2001
the smart solution for Stamford jobs

Data Manager, Clinical & Biomarker Data Management

Company: Loxo Oncology, Inc.
Location: Stamford
Posted on: October 19, 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, Executive , Stamford, Connecticut

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Cargo Manager
Description: To lead, plan and manage all operational activities associated with cargo service handling in line with our procedures, policies and brand values. Job Responsibilities Full responsibility for delivering (more...)
Company: Swissport
Location: Vauxhall
Posted on: 10/23/2020

Cargo Manager
Description: To lead, plan and manage all operational activities associated with cargo service handling in line with our procedures, policies and brand values. Job Responsibilities Full responsibility for delivering (more...)
Company: Swissport
Location: Kenilworth
Posted on: 10/23/2020

Jr Art Director/ Neon
Description: JOB OVERVIEW br br The Junior Art Director Jr. AD must have a basic understanding of FCBH departmental procedures, such as routing, print production protocols, usage rights of stock images for layout, (more...)
Company: FCB
Location: New York
Posted on: 10/23/2020


Cargo Manager
Description: To lead, plan and manage all operational activities associated with cargo service handling in line with our procedures, policies and brand values. Job Responsibilities Full responsibility for delivering (more...)
Company: Swissport
Location: Secaucus
Posted on: 10/23/2020

Cargo Services Manager
Description: To lead, plan and manage all operational activities associated with cargo service handling in line with our procedures, policies and brand values. Job Responsibilities Full responsibility for delivering (more...)
Company: Swissport
Location: Cranford
Posted on: 10/23/2020

Cargo Operations Manager
Description: To lead, plan and manage all operational activities associated with cargo service handling in line with our procedures, policies and brand values. Job Responsibilities Full responsibility for delivering (more...)
Company: Swissport
Location: Wallington
Posted on: 10/23/2020

IT Manager
Description: Marketing StatementMetroPlus Health Plan provides the highest quality healthcare services to residents of Bronx, Brooklyn, Manhattan, Queens and Staten Island through a comprehensive list of products, (more...)
Company: MetroPlus Health Plan
Location: New York
Posted on: 10/23/2020

Cargo Operations Manager
Description: To lead, plan and manage all operational activities associated with cargo service handling in line with our procedures, policies and brand values. Job Responsibilities Full responsibility for delivering (more...)
Company: Swissport
Location: Verona
Posted on: 10/23/2020

Store Manager - 355
Description:
Company: Five Below
Location: New Hyde Park
Posted on: 10/23/2020

Cargo Services Manager
Description: To lead, plan and manage all operational activities associated with cargo service handling in line with our procedures, policies and brand values. Job Responsibilities Full responsibility for delivering (more...)
Company: Swissport
Location: Lyndhurst
Posted on: 10/23/2020

Log In or Create An Account

Get the latest Connecticut jobs by following @recnetCT on Twitter!

Stamford RSS job feeds