Clinical Laboratory Study Manager – FSP
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Job Description
Clinical Laboratory Study Manager at Parexel, managing quality samples and data for clinical trials. Collaborating with cross-functional teams to support innovative precision medicine studies.
Responsibilities:
- 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
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