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Biomarker Operations Specialist

TSR Consulting Services, Inc.

This is a Contract position in Lawrence Township, NJ posted November 27, 2019.

TSR is a relationship-based, customer-focused staffing company.

For over 40 years TSR, Inc.

and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Industry: Pharmaceutical One of our most prestigious clients is looking for a Biomarker Operations Specialist .

This is a long term opportunity located in the Princeton NJ area.

Skills required: Responsible for developing and documenting the Biomarker Testing Plan (BTP) for 15-25 I-O protocols, ensuring implementation of the BTP, and driving time lines for generation and return of data Will engage internally with medical, clinical, technical and operational leaders to ensure alignment and feasibility and externally with central labs and analyzing labs to ensure success for any outsourced elements of the biomarker strategy Collaborate closely with biomarker scientists to document the program/protocol BTP plan and provide guidance for operationalization Drive assets within your Book of Work, ensuring that all required testing is well defined and documented within supporting systems to facilitate the effective application of Biomarker strategy to our development portfolio Develop and manage project plans for data delivery to ensure timeliness of data for exploratory analyses and clinical results; from specimen selection, routing, testing, return of data, and analysis of results Initiate contracting for biomarker work, ensuring alignment between internal technology leads and vendors, review SOW, identify and request samples shipments Ensure that sample collections, movement, analysis and data sharing are in accordance with protocol and informed consent Track, resolve and appropriately escalate issues related to sample and/or data quality (overseeing consistency, integrity, and completeness of biomarker data generation following review of results) Engage effectively with central labs, external vendors and internal labs to ensure timely and consistent execution of biomarker processing, analysis and data delivery Manage results provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance; reconciles external data against the clinical data; resolves data discrepancies between the external data and the clinical data) Clinical drug development/clinical trial execution Demonstrates in-depth knowledge of biomarkers, Pharmacokinetics or immunogenicity sample activities, including collections and logistics considerations Experience managing multiple projects of significant complexity/global scope, in a highly virtualized team environment Experience with bioinformatics and analytical software tools a plus (i.e.

JMP, Spotfire)
– provided by Dice