Temp, GSPN Harmonization Specialist

The Temp, GSPN Harmonization Specialist provides support for the Global Sample Processing Network (GSPN), Global Harmonization Program, as well as technical inquiries from various departments regarding clinical protocols, specialized testing strategies and budgeting requirements.  The role will support GSPN project initiation, network expansion, and data monitoring efforts as well supporting data monitoring and laboratory compliance for the Global Harmonization program.

Please note: this is a remote, full-time temporary role that is expected to end in September.   

Essential Duties and Responsibilities

• Support project initiation of GSPN studies including protocol development, timeline management, review of qualification data, troubleshooting, and development of supporting documentation. 
• Support the identification and capability assessment of new laboratories to expand the GSPN laboratory network
• Ensure compliance of participating laboratories for the Global Harmonization program which may include data monitoring, instrument change management, troubleshooting, and documentation, as necessary. 
• Act as a main point of contact and liaison between LabConnect and GSPN and Global Harmonization laboratories. 
• Maintain documentation for participating GSPN and Global Harmonization laboratories.
• Perform protocol reviews for new RFPs to identify the testing strategy for LabConnect support.  
• Submit requests for quotes to partner laboratories and review and advise on which quotes to include in the overall proposal to the sponsor. 
• Monitor KPI metrics to ensure laboratory performance standards are met in relation to GSPN and Global Harmonization. 
• Address technical or scientific requests from both internal and external sources, including but not limited to Project Services, Business Development, sponsors, or vendors.
• Triage requests as necessary to subject matter experts within the Scientific Affairs, Technical Affairs or Vendor Management groups.  
• Act as technical/scientific liaison between the client and LabConnect as needed and appropriate via email, client calls and/or meetings. 
• Review validation plans/reports and laboratory data for accuracy and suitability. 
• Interact with U.S. and international laboratories and effectively communicate updates, reports, and recommendations to management teams. 
• Interpret data and KPI metrics and report results to management pertaining to vendor laboratory performance. 
• Provide technical support to troubleshoot specific issues that impact the project. 
• Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations

Education and Experience

• Bachelor's degree in Life Sciences or related field from a four-year college or university. 
• Two years industry-relevant project management, laboratory and/or operational experience. 
• Must be experienced in customer service and possess excellent interpersonal skills.
• Project Management experience preferred.
• Experience with PBMC isolation/DNA extraction preferred.

Skills and Ability

• Ability to understand GLP documentation and records, scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, and PBMC isolation techniques.
• Data review, interpretation, and reporting.
• Exceptional attention to detail.
• Strong communication and organizational skills.

Supervisory Responsibilities:  ​None​

Physical Demands: 

While performing the duties of this job, the occupant is regularly required to:

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.