Biomarker Technical Expert

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

we put down Local candidates only

We provide a competitive pay and benefits package. This position is offering a pay range of $54.11/hr. however, Belcan considers several factors when extending an offer, including but not limited to education, experience, geographic location, and discipline. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law.

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 timelyand quality data delivery.

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

Requirements/Preferences:
Education Minimum Requirement Bachelors Degree
Education Preferred Masters Degree

Skills & Competency Requirements
* Bachelor's degree with 5+years pharmaceutical or biotechnology industry experience required
* 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

Preferences
* Doctoral-level degree with 3+ year relevant experience and discipline or Master's degree with 5+ years in a relevant experience and discipline preferred. Extensive pharmaceutical industry experience and in-depth knowledge of clinical drug development and precision medicine. Project management skills including planning, organizational and time management skills. Global vendor management experience

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, 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.