Senior Precision Medicine Operations Lead

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
• Leads, oversees and mentors less experienced colleagues, and contributes to business process improvement initiatives

Operational Support of Biomarker and Exploratory Analysis:

• Manages all activities related to bio sample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle. May be assigned at portfolio level covering multiple studies.
• 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 bio sample vendors, review proposals/bids, and define contractual scope.
• Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study or portfolio level 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.

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.
• Proficient analytical and problem-solving experience.
• Works independently and capably manages multiple tasks through efficient prioritization.
• Excellent written and verbal communication skills.
• Strong communication and interpersonal skills, with proven ability to build relationships internally and externally.
• Sound leadership and coaching/mentoring skills to develop highly effective teams.
• 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 8 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.
• Science background with significant working knowledge of biological assays.

Education:

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