Manager -Biospecimen

Bristol Myers Squibb

3 - 4 years

15 - 20 Lacs

hyderabad

Posted:1 week ago| Platform:

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Skills Required

data management gcp clinical trials healthcare glp data privacy risk management biomedical recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are seeking a candidate with knowledge of clinical trials and the end-to-end management of biospecimens. You will be an independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials. Critical to this role is the ability to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS s continuous competitive advantage.

Key Responsibilities

Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision.

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 internal systems (if applicable)).

Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance.

Qualifications & Experience

Minimum of 3-4 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent.

Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues.

Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent.

Vendor experience preferred (e. g. , Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc. ).

Biospecimen management experience preferred but not mandatory.

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.

Travel requirement is minimal, 0%- 5% of time, when organization requests

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