Precision Medicine Operations Lead - FSP

Parexel; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Parexel is seeking a biomarker data and trial logistics specialist to support precision medicine studies. You will collaborate with cross-functional teams to plan, track and manage biosamples, data transfers and related operations.

The role involves coordinating with vendors, ensuring regulatory compliance, and contributing to study budgets and dashboards for monitoring biomarker data and operational performance.

Qualifications

• Minimum of 6 years clinical research experience.
• Experience with biosample handling and regulatory requirements is preferred.
• Familiarity with ICH/GCP and FDA regulations is expected.
• Background in biomarker data management and study logistics is desirable.

Responsibilities

• Participates in cross-functional study team meetings to support precision medicine strategy for assigned studies.
• Manages biosample planning, storage, shipping, and data transfer across the study lifecycle.
• Oversees acquisition and testing of biomarker samples and defines contractual scope with vendors.
• Forecasts operational costs, budgeting, invoicing and reporting for study logistics.
• Collaborates with data management and biostatistics to plan data capture, transfer and reporting of biomarker data.
• Provides guidance on collection, storage and shipment of biospecimens for protocol compliance.
• May lead programming for clinical supplies and lab operations and develop dashboards for tracking samples and data.

Skills

Project management

Analytical skills

Communication skills

English proficiency

Budgeting

Stakeholder management

Cross-functional collaboration

Lab data interpretation

Education

Bachelor's degree in life sciences or equivalent

Tools

LIMS

APIs

Linux/Unix

SQL

Job description

When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

Key Accountabilities:

Study Team Support

• Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
• Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing, including anticipating challenges, managing risk across projects and responding queries from internal and external stakeholders
• Works with clinical study teams on the development and review of sample-related sections of study-specific documents such as the clinical protocol, Informed Consent Forms (ICFs) and sample management guidelines.
• Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking

Operational Support of Biomarker and Exploratory Analysis

• Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
• Oversees the acquisition and testing of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc.), liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope.
• Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study-related operations

Data Acquisition and Management

• Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials
• Develops and reviews data transfer specifications and related documents

Human Sample Management Flow and Compliance

• Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol.
• Works closely with relevant stakeholders to ensure all transfers of human samples are documented, tracked, used and destroyed according to standard operating procedures and regulatory requirements

Clinical Trial Supplies and Logistics

• May have a dedicated role as clinical trial supplies and logistics lead, accountable for samples, kits, data operations and processes/standards related to global logistics and specialty vendor management within precision medicine
• Manage and oversee kit inventories, clinical sample collection, tracking and data query resolution, regulatory submission documents related to kits and samples, global import/export documentation and proforma invoices, maintenance of laboratory information management systems (LIMS) and tracking of function specific metrics
• Support the creation, implementation, monitoring and improvement of clinical study logistics strategies focused on precision medicine deliverables, including evaluating emerging technologies and vendors

Samples, Kits and Laboratory Operations Programming

• May have a dedicated role as programming lead for clinical supplies and laboratory operations, supporting the development of tools and dashboards for tracking biomarker samples, kits, logistics and lab data throughout the study lifecycle.
• Use technical tools, systems and programming languages to systematically aggregate, extract, process and assess data, including confidential data, according to industry standards and function or study-specific guidelines
• Assess laboratory databases, resolve queries for biomarker data and support data management leads in database lock activities.

Compliance with Parexel Standards

• Complies with timely completion of required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery

Skills:

• 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
• 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

Knowledge and Experience :

• 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

Education:

• Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.