The Senior Manager, Biosamples Operations Lead will own end-to-end biosample operations across assigned studies/programs - from operational feasibility, vendor selection, and execution of biosample operations activities through analysis and data delivery.
As the primary point of contact for the Study Team on all biosample operations activities, including biomarker and bioanalytical operational activities, you will ensure every biosample is collected, processed, and delivered to the highest quality and regulatory standard, while keeping a sharp focus on patient burden and operational efficiency.
Main Responsibilities
• Provides strategic and expert input for the operational feasibility, implementation and execution of the biosample operations activities in assigned clinical studies/programs.
• Manages biosample management activities in clinical studies with low to moderate
complexity, risk, impact and reach.
• Accountable for planning, implementation and execution of biosample operations activities, ensuring proactive risks and issues management and alignment with overall clinical study timelines
• Owns biosample operations plan and is responsible for its maintenance and adjustments during clinical study conduct.
• Leads cross-functional biosample operations team and manage team meetings to review status of biosample operations activities, discuss risks/issues and agree on appropriate mitigation.
• Acts as the single point of contact (POC) in Study Team on biosample operations related aspects (including biomarker and bioanalytical activities). Ensures timely status updates and escalation of risks/issues to the clinical Study Team.
• Contributes to central lab or assay lab vendor selection and qualification.
• Oversees Central lab set-up, kit management, and ongoing study level vendor performance.
• Manages CRO and central lab interfaces to ensure cross-functional alignment on deliverables.
• Maintains a patient focus approach while delivering the complex requirements of a clinical study, balancing patient burden, sampling requirements, the complexity of collection and the cost implications.
• Responsible for overseeing the biosample lifecycle and compliance to ensure that the biosamples are collected, processed, analysed and stored with the highest degree of quality and according to applicable regulations.
• Reviews and provides input to protocols, ICFs, lab manuals, and regulatory submissions.
• Leads budget planning & forecasting for biosample activities of assigned studies.
• Ensures all activities comply with ICH-GCP, GCLP, biobanking policies, and applicable ethical standards.
• Leads audit and inspection readiness; act as interviewee and prepare regulatory responses.
• Impacts the successful delivery of a program/study and ensure optimized execution of the biosample/biomarker operations strategy on time, within budget and required quality.
• Leverages strategic operational knowledge and serves as subject matter expert for current biosample management processes and regulations.
Required Skills and Education
• Minimum Bachelor’s degree in Biology, Pharmaceuticals, or Life Sciences or related field.
• At least 6+ years of experience in Clinical Operations with a focus on Biosamples management activities in a CRO or pharma setting.
• Proven track record in central lab oversight, vendor management, and Phase I–III biosample logistics.
• Experience in CDx development and/or Bioanalytical requirements, would be advantageous.
• Broad experience across multiple therapeutic areas, trial phases and biosample lifecycle management.
• Comprehensive and working knowledge of GCP, GCLP guidelines and other relevant regulations and requirements for the collection, analysis and storage of clinical biosamples.
• Very good knowledge of biosample management related systems and technologies (LIMS, BRICK, CTMS, etc)
• Demonstrated experience in effectively collaborating with other functions in a complex matrix organization.
• Very good command in English language.
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is 225 500,00 zł - 418 600,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.