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Associate Director, Clinical Sample
3 months ago
Our clinical stage vaccine client here in Boston, MA is growing and looking to add
an Associate Director, Clinical Sample & Vendor Management
(REMOTE) to their Clinical Operations team Essentially this role act as a Clinical Project Manager and be responsible for the end to end planning, implementation, and logistics of biological sample management and laboratory services for one or more clinical studies, including prospective forecasting, inspection readiness, and risk management, and in alignment with the program reporting strategies. AD will be a sample management expert, develop and drive the sample and logistics strategy, and oversees laboratory vendors and/or CRO partner(s) including quality and cost management. Other responsibilities include but not limited to:
Clinical operations project leader for assigned clinical studies who will focus on the laboratory services related sample management, sample logistics, and operationalization of the study testing strategy, including selection and oversight of central laboratories vendors contracted either by CRO partner or by company, and maintaining relationship with our preferred vendors.
Drives creation of robust lab service vendor oversight and management plans; input into study sample / central laboratory vendors accordingly (inclusive of quality plan). Oversees and map end to end process, including sample collection, availability of samples, status of sample transfers, and connectivity to analysis and reporting of results milestones throughout the clinical trials until the final clinical trial report is available, and for interim and meta-analysis (on program level), and other purposes.
Manage agreement and budget including vendor work order development and approval, invoice review, and monitoring spend. Manages vendor work order changes.
Active participant study team meetings, including regular CRO study team meetings. Provides input into protocol training (e.g., Investigator Meeting, CRA training), responsible to review key CRO study operational plans (e.g. laboratory manual, risk management plan, monitoring plan, communication plan, etc.).
Tracks sample management and axillary supply planning and progress, proactively escalates study related issues, including related to time, budget, and quality, to the key stakeholders both internally and externally to ensure timely remediation of issues and application of corrective actions.
Partners with Clinical Immunology to align on the sample kit and logistic plans to ensure quality and timely delivery of samples for testing managed by Clinical Immunology. Point of escalation for sample and documentation issues.
Contribution to clinical trial documents, protocols, CRFs, etc. from the sample management requirements perspective and from general trial management experience
Serves as subject matter expert for central laboratory services aspects of studies.
Requirements:
BS/BA degree or equivalent (background in life sciences or medical technology preferred) AND 6+ years of industry experience (biotech/pharma) with at least 2 years of laboratory project management experience in clinical trials.
Prior experience with global vaccine studies preferred.
Global clinical trial conduct and clinical laboratory operations experience, from start-up to reporting. A thorough understanding of the processes associated with project and study management.
Strong understanding of ICH, Good Clinical Practices (GCPs), clinical, and regulatory operations
Experience in management of vendors and CRO's and managing project to budget
Strong understanding of ICH, GCP and relevant regulatory requirements
Proficiency with MS Project, Microsoft Outlook, Excel, Word, PowerPoint.
Other:
Ability travel globally up to 10% of time.
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