The Biosample Operations Manager (BOM) is 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, PK and PD) for assigned studies. The BOM is an integral part of the Study Management Team (SMT) and provides operational/ project management expertise as it relates to sampling, site and patient logistics, and vendor management to ensure deliverables to the SMT or biomarker scientist provided for analysis. The BOM works closely with the Clinical Trial Leads/ Managers, CRO partners, Site Monitors, Data Management, Biomarker Scientist, etc. to ensure the study protocol and overall program deliverables are met.
· 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. BOM will also oversee the assay laboratory and ensure delivery of assay results and is the key contact for the assay lab.
· Determine timelines and all internal resource needs for all biosample operational activities, ensure these are included in study plans and are appropriately tracked
· Write the Study Sample Management Plan, a functional deliverable to the SMT, to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type.
· Provide input to clinical study protocol and ICF to review for collection and analysis rationale, feasibility of biological sampling and alignment with Roche policies and study/ program plans.
· Utilize operational and project management skills to think through issues to ensure deliverables met; Raise issues to the Sr. BOM program leader, Biomarker Scientist, or SMT as required
· 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)
· Accountable for providing answers to ethics questions with regard to repository samples and Roche policies
· Ensures study adherence to ICH/GCP and SOPs
· Identifies areas of best practice and process improvements
· Proven clinical development experience of working in teams running human clinical studies (phase I-IV), monitoring clinical studies or experience of working in clinical studies at an investigator site
· Proven clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
· Proven critical reasoning skills including the identification and resolution of complex problems
· Detail oriented with the ability to work independently and manage multiple competing priorities
· Proven ability to work successfully under pressure
· Proven planning, organizational and time management skills
· Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
· Proven effective communication and presentation skills
· Proven effective influencing skills
· Proven ability to build and maintain effective working relationships.
· Life sciences degree or higher
**Clin Ops/ Med Affairs background IS A MUST (minimally 2 years) and works in a Clinical Operations department.
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