Senior biosample operations lead for clinical trials

Contract duration: until (possible extension)

Location: Basel

Workload: 50%

Responsibilities

• Contribute to the trial protocol development as it relates to biosample management requirements.
• Translate protocol requirements into laboratory operational planning and set up.
• Initiate contracts and budget negotiations with laboratory trial vendors, facilitate discussions with stakeholders, and push through with deliverables to ensure finalization is within appropriate timelines.
• Oversee activities outsourced to laboratory vendors as it relates to biosample tasks
• Develop a Sample Chain of Custody as part of the Trial Oversight Plans.
• Secure documentation evidencing high quality Sample Chain of Custody within the TMF.
• Liaise with clinical development, translational and pharmacokinetic scientists and clinical teams to establish analysis needs with clinical feasibility
• Establish productive working relationships with sites, vendors, business partners, and other stakeholders.
• Serve as an active member of the Clinical Study Team to obtain and provide updates on the progress of the trial regarding sample management
• Must be able to identify and mitigate risks (and issues) to ensure accuracy in sample collection, delivery, and analysis
• Keep track of follow up items for sample activities within clinical studies
• Draft and review laboratory manuals to ensure accuracy and consistency with the study protocol and clinical needs
• Oversee Lab delivers on sample delivery, query resolutions, negotiating with couriers and external vendors to streamline sample collection and shipment
• Facilitate sample shipments and query resolutions among vendors to ensure timely data delivery as needed
• Manage biobank if relevant
• Identify issues and be proactive in urgently escalating and resolving them
• Track and manage all sample related activities or PK, PD, and Biomarkers routinely and provide updates when appropriate
• Have a strong understanding of scientific needs as well as clinical processes to bridge the needs between these functions
• Understand and assist in data reporting needs for each clinical study
• Drive the development of necessary Biosample Operations SOPs, Templates, and tools by assessing the need for creation of, change to, and removal of procedural documents
• Maintains current knowledge of and ensures all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory, GxP requirements and related policies and procedures. Advocates for full legal compliance and ethical conduct in all business transactions.