Parexel

Clinical Laboratory Study Manager – FSP

Parexel

full-time

Posted on:

Location Type: Remote

Location: Argentina

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Tech Stack

Google Cloud PlatformLinuxPerlPythonSQLUnix

About the role

  • The Clinical Laboratory Study Manager works closely with Precision Medicine Leadership and cross-functional study teams to ensure quality samples and data are proficiently managed.
  • Manage all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle.
  • Oversee the acquisition and testing of clinical trial samples designated for biomarker research, liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope.
  • Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials.
  • Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol.
  • Manage and oversee kit inventories, clinical sample collection, tracking and data query resolution, regulatory submission documents related to kits and samples.

Requirements

  • Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry
  • Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
  • Strong project management and organization skills in a matrix environment
  • Analytical and problem-solving experience
  • Excellent written and verbal communication skills
  • Effective communication and interpersonal skills, with proven ability to build relationships internally and externally
  • Travel not expected but may occur periodically
  • Proficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systems
  • Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations.
  • Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.
Benefits
  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchclinical drug developmentdata managementbiostatisticsproject managementanalytical skillsproblem-solvingPythonRSQL
Soft Skills
organization skillswritten communicationverbal communicationinterpersonal skillsrelationship building