Biomarker Technical Expert

TekWissen LLC

Cambridge, MA(remote)

JOB DETAILS
SALARY
$52–$52
SKILLS
Agriculture, Analysis Skills, Bioinformatics, Biomarkers, Biostatistics, Biotech and Pharmaceutical, Budgeting, Clinical Laboratory, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Analysis, Data Collection, Data Formats, Data Management, Data Processing, Data Sets, Detail Oriented, Diversity, Documentation, Drug Development, GCP (Good Clinical Practices), Healthcare, ICH Regulations, Laboratory, Laboratory Management, Leadership, Logistics, Medicine, Multicultural, Multitasking, Oncology, Operations Planning, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Quality Control, Reconciliation, Regulatory Submissions, SSL-TLS (Secure Socket Layer - Transport Layer Security), Specimens/Samples, Startup, Technical Support, Time Management, Translational Research, Vendor/Supplier Management, Workforce Management, Writing Skills
LOCATION
Cambridge, MA(remote)
POSTED
7 days ago
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:
  • 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
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
TekWisen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/