Clinical Operations Manager

Mindlance; Illinois; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Mindlance seeks a Biomarker Sample Operations Manager to lead the collection, processing and transfer of clinical trial biomarker specimens. You will partner with program managers, lead scientists and IT to ensure data accuracy, regulatory compliance and timely delivery of samples to labs.

The role requires a strong scientific background in oncology, excellent communication, and the ability to work with minimal supervision in a hybrid Lake County or South San Francisco setting.

Qualifications

• Master’s or Bachelor’s degree with 3+ or 4+ years in project management in oncology/biomarkers.
• Strong MS Office skills and ability to communicate clearly in English.
• Clinical trial experience and ability to work with limited supervision.

Responsibilities

• Plan and oversee collection and shipping of bio-samples to assay labs.
• Coordinate with program managers to meet study timelines and data transfer.
• Improve biomarker sample handling, processing, storage and destruction processes.
• Review study docs, create checks for sample types, and liaise with labs and vendors.
• Support contracts and vendor oversight; ensure timely escalation of issues.

Skills

Communication

Organizational skills

Analytical skills

Independent work

Education

Master’s Degree

Bachelor’s Degree

Tools

MS Office

Job description

Biomarker Sample Operations Manager - III

Length of assignment: 2 years

Location: Hybrid in Lake County. LC is preferred but candidate can also be hybrid in South San Francisco

Purpose:

The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials. The Biomarker Sample Operations Manager works closely with clinical operations, project managers and laboratory managers to ensure timely and smooth collection, transfer and testing of clinical trial biomarker specimens in compliance with protocols, regulatory requirements and project timelines. This role is responsible for identifying projects/tasks together with laboratory managers and works with biomarker study management teams to complete tasks. This role will drive innovation and continuous improvement activities in bio-sample collection, processing and transfers, and demonstrate ability to carry out all bio-sample operations with minimal supervision.

Responsibilities:

• Plan, organize and oversee the collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to assay laboratories.
• 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 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.
• 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

Qualifications:

• Master’s Degree with 3+ years project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• Bachelor’s Degree with 4+ years of project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• 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
• Clinical trial experience
• Scientific background and knowledge of oncology.
• Ability to work with minor supervision

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”