Biosample Operations Manager

Proclinical is currently recruiting for a Biosample Operations Manager with a leading biotechnology company located in New York, NY. Successful candidate will be accountable for the execution of the biomarker strategy that includes the planning and coordination all operational activities required for the collection and delivery of clinical trial samples (Biomarker and Immunogenicity) for assigned studies.

Job Responsibilities:

• Main point of contact for planning and coordination all operational activities required for the collection and delivery of clinical trial samples (Biomarkers, immunogenicity, etc.) for assigned studies.
• Engage effectively with central labs, external vendors and internal labs to ensure timely and consistent execution of biomarker processing, analysis and data delivery.
• Collaborate closely with biomarker scientists to document the program/protocol biosample plan and provide guidance for operationalization. Implement this plan when working with central labs, confirming collection kit components and design.
• Provide operational/ project management expertise as it relates to sampling, site and patient logistics, and vendor management to ensure deliverables to the study management or biomarker scientist provided for analysis.
• Accountable for planning, organizing and overseeing the collection and shipping of biosamples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality.
• Maintain oversight of all study biosample operational activities (for agreed samples) and regularly report on status (including sample collection and reconciling against consent; Sample reconciliation activities as required).
• Determine timelines and all internal resource needs for all biosample operational activities, collaborating with the biomarker scientist to ensure all collected samples are available for required analyses per the planned analysis timelines.
• Provide input to clinical study protocol and ICF to review for collection and analysis rationale, feasibility of biological sampling and alignment with study/ program plans.
• Contribute to contracting for central lab and biomarker work, ensuring alignment between internal team members and vendors, review SOW, identify and request samples shipments.
• Track, resolve and appropriately escalate issues related to samples and/or data quality.
• Ensure study adherence, regarding biosamples, to ICH/GCP.
• Actively partners with CRO Data Management to oversee and coordinate biomarker data format and delivery timelines Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work.

Skills and Requirements:

• Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required.
• 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R D environment.
• Clinical development experience of working in teams running human clinical studies (phase 0-IV), monitoring clinical biosamples.
• Vendor management experience of overseeing central labs.
• Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
• Critical reasoning skills including the identification and resolution of complex problems.
• Detail oriented with the ability to work independently and manage multiple competing priorities.
• Ability to work successfully under pressure.
• Planning, organizational and time management skills.
• Effective communication and presentation skills.
• Ability to build and maintain effective working relationships.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Susan Chapman at (+1) 646-542-0158 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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