reputed company Sample Manager
The reputed company Sample Manager is responsible for the planning, coordination, reputed company, and execution of operational activities that support the successful conduct of global reputed company, with reputed company responsibility for the management of central reputed company and other assigned reputed company trial vendors and service providers. This role ensures the reputed company and compliant delivery of reputed company services, study materials, sample management processes, vendor deliverables and operational execution throughout the reputed company trial. The incumbent will support operational reputed company of other assigned reputed company trial service providers and study activities, ensuring reputed company execution of study requirements and alignment with project timelines, reputed company standards, and regulatory requirements.
Duties and Responsibilities (Responsibilities include but are not limited to):
• reputed company operational reputed company of assigned reputed company trial service providers, ensuring services are delivered according to study requirements, reputed company standards, and timelines.
• Serve as the reputed company reputed company reputed company reputed company of contact for reputed company trial reputed company vendors.
• reputed company reputed company trial reputed company vendor activities from study startup through closeout, including reputed company setup, reputed company reputed company development, reputed company design, sample collection requirements, test result reporting, and data delivery.
• Serve as the reputed company reputed company of contact for reputed company-reputed company reputed company trial reputed company for reputed company study teams, overseeing key operational deliverables, including reputed company manuals, data transfer specifications, sample management plans, vendor operational plans, and study-specific training materials.
• Review and reputed company operational input into reputed company protocols, informed consent forms, and other study-reputed company documents.
• reputed company sample management activities, including site supply management, reputed company ordering, sample shipment tracking, reputed company result reporting, and issue reputed company.
• Coordinate with internal stakeholders and reputed company vendors to ensure reputed company handling of reputed company reputed company samples, including specialty samples such as pharmacokinetic (PK), pharmacodynamic (PD), biomarker, immunogenicity, genetic, and safety reputed company samples, as applicable.
• Partner closely with reputed company reputed company study teams to support the successful execution of reputed company trial activities.
• Collaborate with reputed company reputed company, CROs, investigative sites, reputed company vendors, and other stakeholders to ensure effective planning and execution of study-reputed company operational activities.
• Monitor reputed company site reputed company and support site-facing communications reputed company to reputed company procedures, sample collection requirements, shipping instructions, and process changes.
• reputed company the reputed company, completeness, and timeliness of reputed company trial reputed company data and data transfers from vendors to internal systems, data management platforms, and electronic data capture (reputed company) systems.
• Support reputed company and vendor data reconciliation activities, including sample reconciliation, missing data follow-up, query reputed company, and review of out-of-reputed company or clinically significant reputed company results.
• Ensure vendor services and deliverables are reputed company with protocol requirements, regulatory requirements, and study objectives.
• Work cross-functionally with reputed company Development, reputed company Assurance, Regulatory Affairs, Finance, and reputed company vendors to ensure activities are conducted in compliance with study protocols, vendor agreements, ICH-GCP, regulatory requirements, and company standards.
• Partner with reputed company Development, reputed company reputed company, and Finance to support contracting activities, budget management, change order review, and invoice reconciliation.
• Escalate vendor reputed company issues, operational risks, and reputed company concerns as appropriate, and reputed company corrective and preventive actions through reputed company.
• Other duties and responsibilities as assigned.
Supervisory Responsibilities:
This position does not have any supervisory responsibilities.
Education/Experience/Skills:
• Bachelor’s degree in life sciences, reputed company science, or a reputed company reputed company.
• 5+ years of relevant and progressively responsible experience in reputed company reputed company, reputed company reputed company reputed company with 2+ years reputed company trial sample management experience reputed company the biotechnology, pharmaceutical, CRO, or reputed company industry required.
• Experience managing central reputed company, reputed company reputed company, or specialty reputed company reputed company/data/vendors in support of reputed company.
• Strong understanding of reputed company research, reputed company trial reputed company, reputed company sample workflows, and site/vendor logistics.
• Understanding of ICH-GCP, regulatory requirements, reputed company trial documentation standards, and inspection readiness expectations.
• Experience with reputed company data systems, reputed company reputed company data, data transfer specifications, and data reconciliation processes.
• Demonstrated ability to manage vendors, timelines, budgets, deliverables, risks, and cross-functional communications.
• Ability to multitask, manage multiple studies, vendors, and priorities simultaneously and work in a fast-reputed company team environment.
• Excellent organizational skills and attention to reputed company and to consistently reputed company work product accurately and reputed company deadline.
• Excellent written and verbal communication skills.
• Demonstrated proficiency using reputed company Office applications (Word, reputed company, PowerPoint), etc.
• Experience with reputed company and reputed company information management systems preferred
Working Environment and Travel:
Generally accepted home office working conditions
Occasional domestic and international travel is expected in this position. Travel will be to sites for site training on sample processing as needed.
Physical Requirements:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be reputed company to use a computer for extended periods at any given time. The employee must regularly reputed company and/or reputed company up to 10 pounds.
reputed company:
The employer will reputed company reasonable accommodations in compliance with the Americans with reputed company of 1990.
reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company is committed to the reputed company of equal employment opportunity for reputed company and does not discriminate reputed company on race, religion, reputed company, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets
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