Manager, Biospecimen Planning Lead @ OM Sai

Job Description

Position Summary Manager, Biospecimen Planning independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-2a clinical trials and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies initially under the guidance of senior colleagues and work across the organization and with BMSs partners to implement and project manage efforts to execute these strategies. Critical to this role is the ability to provide innovative solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMSs continuous competitive advantage. The individual will be responsible for supporting biospecimen management for the Early Development assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens. Position. Responsibilities Oversee and manage the complete lifecycle of biospecimens collected for early phase clinical studies with minimal supervision. Core Clinical Team member responsible for providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.). Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed. Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking. Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with support. Able to identify biospecimen related risks with support from risk library. May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed. Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines. Maintain intermediate working knowledge of compound and study related biospecimen requirements. Ensure completion of individual Study Transition Forms Able to identify biospecimen related risks with support from risk library. May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed. Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines. Maintain intermediate working knowledge of compound and study related biospecimen requirements. Ensure completion of individual Study Transition Forms Able to identify biospecimen related risks with support from risk library. May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed. Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines. Maintain intermediate working knowledge of compound and study related biospecimen requirements. Ensure completion of individual Study Transition Forms Experience Requirements Minimum of 6 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data and risk management. Experience desired but not limited to: biospecimen life-cycle/operations, compliance, management and vendor management. Key Competency Requirements Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Vendor experience preferred (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.). Ability to develop skills with training for stakeholder management including conflict and change management. Biospecimen Operations Experience preferred but not mandatory. Developing knowledge of the drug discovery or developmental process. Applies Scientific and/or functional knowledge to conduct studies in assigned area. Ability to effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, with limited supervision. Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Operations Management / Process AnalysisGeneral / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Manager, Biospecimen Planning Lead

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Keyskills:   Clinical Trials Asset Management Vendor Management Risk Management Data Management Stakeholder Management Conflict Management Change Management Drug Discovery Biomedical Research GCP GLP Biospecimen Planning Protocol Management CLIA Biopharma