Biomarker Sample Operations Lead

Spectraforce Technologies, Inc.; North Chicago (IL); Hybride; USD 110 000 - 150 000; Plein temps

Résumé du poste

Spectraforce Technologies, Inc. is seeking a Biomarker Sample Operations Manager to lead the collection, transfer and testing of clinical trial biomarkers in a hybrid setting (North Chicago, IL or South San Francisco, CA).

The role partners with operations, project managers and laboratory managers to ensure timely delivery in compliance with protocols and timelines. Candidates will have a Master’s or Bachelor’s degree with PM experience in oncology/clinical trials, strong MS Office skills,

Qualifications

• Master's degree with 3+ years project management in oncology or clinical trials.
• Bachelor's degree with 4+ years project management in oncology or clinical trials.
• Expertise in MS Office applications including Excel, Word and PowerPoint.
• Excellent oral and written communication skills in English.
• Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills.
• PMP certification a plus.
• Clinical trial experience.
• Scientific background and knowledge of oncology.
• Ability to work with minor supervision.

Responsabilités

• Plan, organize and oversee the collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to assay laboratories or our organization.
• Partner with Biomarker Program Manager and Biomarker Lead Scientist to ensure the delivery of bio-sample data in accordance with study timelines.
• Ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases for each assigned study, reconcile sample information stored in databases.
• Responsible for functional process and system improvements to ensure samples are collected, processed, analyzed, transported, stored and destroyed appropriately.
• Review study-specific documents related to sample collection, handling, analysis, transport and storage as assigned.
• Create edit checks for each sample type within assigned trials.
• Manage relationships with laboratory vendors, provide input into trial-specific docs and assess service level commitments of labs involved in sample analysis.
• Ensure issues are resolved or escalated in a timely manner.
• Review lab vendor invoices to ensure work has been completed.
• Help project managers with contract execution and vendor oversight in compliance with our organization procedures and applicable regulations.
• May oversee laboratory vendor deliverables against the scope of work.
• In partnership with Biomarker Program Managers, Biomarker Lead Scientists and IT, contribute to the development and implementation of a sample tracking system for assigned studies.
• Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines.
• Develop into a subject matter expert (SME) and resource for one or more processes in BPM.
• Participate in process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes.
• Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels mentor and develop team members as needed.
• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed.

Connaissances

Project management

Communication skills

Analytical skills

Time management

Interpersonal skills

Independent work

Formation

Master's degree

Bachelor's degree

Outils

MS Office

Excel

Word

PowerPoint

Description du poste

Spectraforce Technologies, Inc. is seeking a Biomarker Sample Operations Manager to lead the collection, transfer and testing of clinical trial biomarkers in a hybrid setting (North Chicago, IL or South San Francisco, CA).

The role partners with operations, project managers and laboratory managers to ensure timely delivery in compliance with protocols and timelines. Candidates will have a Master’s or Bachelor’s degree with PM experience in oncology/clinical trials, strong MS Office skills,