Clinical Laboratory Study Manager – FSP
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Job Description
Clinical Laboratory Study Manager overseeing biosamples, laboratory vendors and biomarker data for Parexel’s clinical development solutions. Supporting precision medicine delivery across clinical studies in Argentina.
Responsibilities:
- Work with the Precision Medicine Strategy Lead, clinical study teams, data management team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data support biomarker and non-biomarker evaluation
- Oversee clinical sample collection, usage per informed consent form, sample tracking and chain of custody
- Manage central laboratory and specialty vendors and sample destruction
- Support generation of quality laboratory data and resolve sample-related issues or queries
- Participate in cross-functional study team meetings and workstreams
- Provide subject-matter expertise on sample management and testing, anticipate challenges, manage risk and respond to stakeholder queries
- Develop and review sample-related sections of clinical protocols, Informed Consent Forms and sample management guidelines
- Support creation and validation of specialty laboratory databases for data collection and sample kit tracking
- Manage biosample process planning and execution, including storage, shipping and data transfer
- Oversee acquisition and testing of clinical trial samples for biomarker research
- Assess biosample vendors, review proposals/bids and define contractual scope
- Forecast operational costs and timelines; manage budgeting, invoicing and reporting
- Determine how biomarker data is captured, blinded, transferred and reported
- Develop and review data transfer specifications and related documents
- Guide and train clinical teams and investigative sites on biospecimen collection, storage and shipment
- Ensure human sample transfers are documented, tracked, used and destroyed according to SOPs and regulatory requirements
- Manage clinical trial supplies and logistics, including kit inventories, sample tracking, regulatory submission documents and global import/export documentation
- Maintain laboratory information management systems and track function-specific metrics
- Support logistics strategies, technology and vendor evaluations
- Develop tools and dashboards for biomarker samples, kits, logistics and laboratory data when acting as programming lead
- Use technical tools, systems and programming languages to aggregate, extract, process and assess data
- Assess laboratory databases, resolve biomarker data queries and support database lock activities
- Complete required training, timesheets, expense reports and CV updates
- Maintain effective relationships across platform, business, research and enabling lines
Requirements:
- 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
- Fluent in speaking/writing English
- 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, and familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations
- 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
- Working knowledge of ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
- 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:
- No specific benefits or compensation extras stated
- Travel not expected but may occur periodically
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