Biomarker Technical Expert

• 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.

• 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

• Education Minimum Requirement Bachelors Degree
• Education Preferred Masters Degree

• 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

• 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

TekWissen is an emerging global human capital recruitment and IT services organization. Operating since 2009 we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We re founded on a culture that is passionate about delivering tailored solutions that create lasting partnerships.

Our global footprint covers six countries: United States Canada Australia India United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies to single sites with lower recruitment volumes.

TekWissen is an equal opportunity employer supporting workplace diversity.