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Lead, Bioassay and Sample Management
2 settimane fa
The Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.
As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and oversees central laboratory vendors, ensures compliant and on time delivery within budget across global laboratory programs.
The L-BSM is a key member of the Study Execution Teams (SETs), an ad-hoc member of other Clinical Development Teams, overseeing outsourcing for routine sample testing, and takes preventive/corrective action(s) to address issues/risks associated with sample activities.
In this role you will support budget management, protocol development and feasibility activities, providing guidance where required. As well as being responsible for ensuring that all sample activities are conducted in accord to GCP, GCLP and to all relevant guidelines within a QA-regulated environment.
This role reports into the Associate Director of Bioassay and Sample Management (BSM), and Interfaces with Snr/Global Trial Leads and other CDO roles, Therapeutic Area Program Directors, Principal/Clinical Scientists, Clinical Trial Supplies, Therapeutic Area Statisticians and others.
As part of our Flexible working policy the role holder will be required to work 2 days a week on site at the office.
Responsibilities include:
- Responsible for the planning, oversight of in-study end to end sample management including central testing and reporting across global portfolio of clinical trials: Provide sample management expertise and input to clinical protocol and associated documents.
- Responsible for project managing all aspects of the end-to-end clinical sample lifecycle, including, but not limited to:
- Sample collection protocols,
- Sample shipment from clinical/investigator sites/depots to external vendor 300+ sites across 15+ countries),
- Ensuring central testing is being conducted according to the optimised, validated protocol(s),
- Review of budget for clinical sample testing and logistics.
- Issue/risk identification and resolution; ensure escalation pathway to Snr/GTL and/or Program Director, as needed.
- Responsible for identifying, evaluating and selecting external vendors capable of conducting central lab activities and sample testing to support pivotal global clinical trials. Accountable for oversight of clinical samples vendors and ensuring quality of data is robust and per validated protocols.
- Responsible for managing clinical samples per country regulations and/or informed consent procedures. Capability to oversee and manage complex sample collection and shipping process across global regions (Asia Pacific, Americas (NA and LATAM), Europe, Middle East and Africa).
- Review validation protocols for clinical testing and ensures testing is in compliance with clinical protocol, local regulations and Good Clinical Practice
- Establishes and maintains close relationship with manufacturing facilities and External Reference Laboratories.
- In collaboration with Research and Clinical Bioanalytics (RCB) and Vaccine Innovation Unit (VIU) serology functions drive optimization of assays and/or changes to testing procedures as requested by Regulatory Authorities
- Provision of serology expertise in responding to Regulatory Agency questions regarding serology testing.
- Responsible for ensuring contracts with external testing and sample processing vendors are executed in a timely manner and are cost effective.
Qualifications, Skills and Experience:
- As a guide, a minimum 5+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.
- Experience in overseeing global vendors supporting clinical trials, sample testing and sample logistics and storage.
- Clinical Research experience in at a least 1 relevant TA: Immunoglobulins/Vaccines/Transplant & Immunology/Hematology/Cardiovascular and Renal
- Experience with project management software packages.
- Budget forecasting and review.
- Thorough knowledge of ICH, GCP and GCLP guidelines.
- Experience in working in a QA-regulated environment.
- Ability to work independently with low level of oversight in the support and/or management of clinical trial execution.
- Demonstrated ability to work in a fast-paced team environment.
- Experienced in working within a Matrix Environment
- Excellent interpersonal and decision-making skills.
- Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report.
- Ability to plan and ensure execution and completion of serology testing to the highest ethical and scientific standards.
- Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
- Extensive and comprehensive knowledge of ICH guidelines/GC
