Biomarker Technical Expert

Job Title: Biomarker Technical Expert
Location: Cambridge, MA
Zip Code: 02142
Keyword's: #BiomarkerTechnicalExpert; #CambridgeJobs;
Start Date: Immediate

Position Summary
The primary responsibility of this role is to provide biomarker technical expertise and support to the Translational Science Lead (TSL) to ensure operational implementation and execution of translational science strategies in clinical trials which may include phase I, II and III studies.
The BTE is responsible for all operational and logistical aspects of carrying out biomarker related activities to ensure timely and quality data delivery.
Workload includes multiple projects in the area of oncology.
The BTE will interface with the TSL and multiple functions throughout the company as well as external partners to support and facilitate biomarker activities including clinical trial start up, sample logistics, lab vendor management (including companion diagnostics partners), data management related support for data collection, transfer, reconciliation and reporting, document preparation, budget support, and more.

Position Duties and Responsibilities
* Collaborate closely with TSL, Clinical Operations, Biostatistics/Bioinformatics, and data management teams to support and execute translational science strategies in clinical trials
* Develop and provide operational input into all study related documentation and processes, and ensure collection, delivery and analysis of biomarker samples in compliance with these documents as well as GCP/ICH
* Serve as a single point of contact for biomarker operations across functions, and with collaborators and CROs.
* Work with data management for set-up and application of biomarker-relevant pages, coordination of biomarker data format and delivery timelines, data transfer specification setup, to ensure timely and efficient data delivery (data transfers, reconciliation, analysis, reports), mutual data transfers with Companion Diagnostics (CDx) partners for CDx regulatory submissions, if needed
* Lab vendor management including contracting, data QC and delivery timelines, data transfers and reporting
* Manage implementation and execution of clinical biomarker sample logistics and operations including site feasibility and training, sample management plan, lab manual, monitoring of proper delivery
* Provide real-time sample oversight and drive ongoing sample reconciliation to support selection of samples for analysis
* Support Data analysis including processing of data files, curation and integration of datasets, generation of tables, figures and listings

Skills & Competency Requirements
* Bachelor's degree with 5+years pharmaceutical or biotechnology industry experience required
* Clinical laboratory experience including involvement in the processing and/or analysis of clinical samples
* Critical reasoning skills including identification and resolution of complex problems and detail oriented with the ability to work independently and manage multiple competing priorities
* Proven project leadership skills, ability to successfully achieve results within multi-cultural and geographically diverse teams
* Excellent oral/written communication skills

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.