This is what you will do:
You will be a key member of the Clinical Trial Teams to which you are assigned, ensuring that all clinical samples required within the protocols are collected, shipped, analyzed and stored, with high quality and compliance. As a result of your expertise and efforts we will optimize the use of our clinical trials samples to meet protocol requirements, deliver on our promise to our rare disease patients and advance our science by ensuring our scientists have timely access to all available samples to answer new research questions.
You will oversee clinical sample life-cycle management within ARDU and across external labs and third-party vendors for the clinical trials to which you are assigned. To do so, you will partner with Clinical Operations, Data Management, Clinical Development and multiple members of the Research team to build, implement and manage the end-to-end clinical biospecimen logistics both globally and locally, including oversight of lab vendor setup, tracking, collection materials and laboratory operational plans.
The role requires a combination of scientific and project management expertise with excellent attention to detail.
You will be responsible for:
• Manage clinical samples from multiple global clinical trials and maintain sample chain-of-custody in a GxP-compliant setting
• Accountable for clinical sample logistics planning and coordination with Clinical Operations, clinical sites, external labs, vendors, and couriers to define sample processing and movement timelines needed for sample testing and transfer.
• Oversee all operational activities required to ensure high quality sample processing, shipping, receiving, and storage of biological research samples
• Collaborate with Clinical Operations, Data Management, Biostatistics, and vendors for data transfer and analysis need
• Potential direct contact to CRA or Project managers
• Input to kit design, sample processing, collection storage and shipping
• Establish overall clinical lab sample accountability strategy across studies
• Tracking lessons learned and apply them across trials for consistency and continuous improvement activities
• Contribute to clinical lab training materials & review of laboratory manuals
• Support virtual or onsite training meetings
• Support communications and build relationships with key stakeholders including CROs, vendors and external collaborators
• Ensures completion, deployment and accuracy of the Clinical Sample Management Plan, or equivalent
• Utilizes tracking systems to report progress, address issues and resolution.
• Represent sample operations at meetings to ensure deliverables related to clinical samples are met.
• Responsible for innovative sample management process improvement.
• Liaise with Data Management, Clinical Operations, and Translational Research to resolve research sample related data reconciliation, and sample related issues at sites or analysis labs
• Provide input into clinical trial protocols/synopses and informed consent forms to ensure logistical feasibility of clinical sample strategy as well as alignment with all Clinical Sample Plans, ICH/GCP, and local regulations.
• Assist with tracking appropriate metrics
• Support Health Authority inspections as needed
You will need to have:
• Minimum of 8+ years of biopharmaceutical R&D experience in drug development and participation in projects involving vendors and cross-functional teams, or equivalent experience.
• Direct experience with clinical sample management and/or clinical trial management
• Knowledge of GCP requirements
• Ability to work effectively in a fast-paced environment to meet deadlines with a can-do attitude
• Excellent communication and organizational skills, along with problem solving and conflict resolution
• Proficiency in MS Office (i.e. Word, Excel, PowerPoint), Adobe Acrobat and SmartSheet
Note: The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
• A degree in life sciences ( e.g. BSc, MSc) or regulatory compliance.
• Experience in implementing and using sample management/tracking systems, i.e. Laboratory Information Management System (LIMS)
• Knowledge of GLP requirements
• Experience with rare disease clinical trials
• Project management and/or Lean Six-sigma training