Xcene Research

Clinical Laboratory Specialist

Xcene Research

Medical & Pharmaceutical

Healthcare NGN 150,000 - 250,000
1 month ago

Job Summary

Xcene Research dedicated to producing and delivering accurate data from all clinical trial phases engages the expertise of the Clinical Laboratory Specialist who serves as the primary point of contact for lab data management deliverables. The CLS has a thorough understanding of study protocols and lab manuals, ensures sample processing is completed correctly, monitors the laboratory and supplies needed as well as drives efficiency and accountability throughout the trial process.

  • Minimum Qualification:Degree
  • Experience Level:Mid level
  • Experience Length:3 years

Job Description/Requirements

Responsibilities:

  • Leading multi-geographical and cross-functional teams, delivering large-scale clinical projects as it relates to laboratory matters.
  • Provide project progress to leadership teams through weekly conference calls, daily/weekly packaging updates, and conducting business review meetings.
  • Manage all the laboratory logistical aspects of phases 1-4 clinical trials. Interfacing with Sponsor as a primary operational laboratory manager.
  • Manage clinical, analytical, data management, pharmacokinetic and biostatistical components of projects ranging from multiple protocols and laboratory manuals.
  • Work directly with sites as their main point of contact for all laboratory needs.
  • Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced, and objective manner.
  • Coordinate, attend and facilitate weekly project calls to track progress versus plan, proactively identify and manage project risks, implement solutions, and apply corrective and preventive actions.
  • Lead the development and implementation of internal processes to manage projects and support laboratory processes.
  • Coordinate laboratory supplies and utilization, evaluate current study needs, oversee the acquisition, and shipping of supplies, anticipate, and plan for future needs.
  • Assisting teammates with on-site visits from site selection through close-outs; training clinical site staff on the implementation and conduct of study laboratory protocols.
  • Monitoring conduct, and compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing laboratory knowledge to achieve optimal results, and following up on the handling of biological samples at site and when in transit.
  • Ensuring high-quality of projects that comply with applicable local, and international regulations (GLP, GCP, FDA, EMA) and Xcene’s Quality Management System.
  • Establish efficient vendor management processes.
  • Develops and maintains SOPs and work practices applicable to a global organization.
  • Proactively communicating with the sponsor and internal groups ensuring that they have all the information required on project progress and status regarding laboratory matters (risk analyses, what-if scenarios, contingency plans, technical information, significant changes of any kind, etc.).
  • Prioritize effectively and respond to urgent requests within a team or from sponsors.
  • Review the applicable project contract/exhibit and provide comments as appropriate.
  • Implements an efficient contracting and vendor selection process.
  • Periodically review laboratory processes across clinical trial projects to ensure compliance and consistency.
  • Prepare, participate in, and follow up on audits/inspections.
  • Resolve any issues from site visits in a timely way.


Requirements:

  • Bachelor’s degree (or equivalent) level of qualification in Medical Laboratory Science (MLS) or equivalent combination of education and experience
  • Strong understanding of lab tests, units, and ranges.
  • Team player with the ability to work with technical and clinical team members.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

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