Biomarker Technical Expert

TekWissen LLC

Job Location:

Cambridge, MA - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor; Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.

Job Title:Biomarker Technical Expert

Location:Cambridge MA 2142

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Remote

Job Description:

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.
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

Requirements/Preferences:

Education Minimum Requirement Bachelors Degree
Education Preferred Masters Degree

Skills & Competency Requirements:

Bachelors degree with 5years 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

Preferences:

Doctoral-level degree with 3 year relevant experience and discipline or Masters 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

TekWisen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor; Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies ...