Nextrials, Inc. · 9 hours ago
Scientific Affairs Specialist II
United States
Full-time
Remote
Senior Level
5+ years expNextrials, Inc. is a leading healthcare intelligence and clinical research organization. The Scientific Affairs Specialist II will serve as a key scientific liaison supporting a global central laboratory's clinical and operational activities, ensuring scientific rigor and alignment with regulatory expectations.
Health CareMedicalSoftware
Responsibilities
Maintain and configure testing and assay summary information in the Test Master application of the ICOLIMS system
Configure test codes within the STARLIMS system
Assist all other ICL departments with Global Scientific Affairs related issues and questions
Utilize the internet, journals, internal validation documentation, etc. to update specimen requirements, stability, and transport information within departmental databases
Follow SOPs relevant to Global Scientific Affairs issues
Provide scientific notifications and technical documentation to Global Client Services
Assist in scientific consistency across global studies and laboratory sites
Assigns work from the Scientific Affairs Inbox and assures that all Service Level Agreements for TAT are met
Lead the collaboration in support of Client Services requests, with regards to special collection instructions
Attend meetings with both internal and external clients on behalf of Global Scientific Affairs
Provide notifications of testing changes and updates to ultimately Global Client Services
Provide scientific input on assay selection and reporting interpretation
Support troubleshooting of complex scientific or technical issues in collaboration with laboratory and leadership teams
Act as a scientific point of contact for sponsors, investigators, and internal commercial teams
Participate in client meetings and scientific consultations
Identify opportunities to enhance scientific processes and knowledge sharing across the organization
Support implementation of new technologies, assays, or biomarkers into the central laboratory portfolio
Qualification
Required
5+ years of experience in scientific affairs, central laboratory services, or diagnostics, in a CRO, biotech, or pharmaceutical environment
Hands-on knowledge of clinical trial laboratory operations and assay methodologies (e.g., immunoassays, molecular assays, flow cytometry, genomics)
Knowledge of clinical laboratory concepts and terminology
Detail-oriented, with strong organizational skills and ability to manage multiple priorities
Strong scientific and analytical skills with the ability to interpret complex data
Excellent written and verbal communication skills for both scientific and non-scientific audiences
Proven ability to collaborate in cross-functional, multicultural, and global teams
Proficient in Microsoft Office Suite, specifically Excel
Bachelors Degree in Medical Technology or related field
Preferred
Experience supporting global or multi-regional clinical studies
Experience with STARLIMS
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Company
Nextrials, Inc.
Founded by bio-pharmaceutical researchers in 1999, Nextrials offers today’s most advanced e-clinical tools and services for speeding the delivery of lifesaving drugs and medical devices to market.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2016-03-18Acquired
Leadership Team
J
Jim Rogers
Founder, President and CEO
L
Lecia Shaffer
Clinical Operations
Company data provided by crunchbase