Manager, Biospecimen Management at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

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.)
Ability to develop and implement biospecimen management plans for Phase 1-4 clinical trials and externally acquired biospecimens (implied from role summary)
Ability to work independently with minimal supervision on biospecimen lifecycle management (implied from duties)

Responsibilities

Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision
Serve as 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 review clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed
Perform routine vendor management responsibilities, including requesting and/or accessing necessary vendor/system inventory files to perform specimen tracking
Create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris) with support under direction
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
Exercise judgment within policy and procedure boundaries; troubleshoot routine problems and understand when appropriate to ask for guidance; may need assistance to prioritize BOW activities during critical deadlines
Maintain intermediate working knowledge of compound and study related biospecimen requirements
Develop and execute asset and protocol-level biospecimen strategies; work across the organization and with partners to implement and project manage efforts (from position summary)

Skills

Biospecimen Management

Clinical Trials

Project Management

Lifecycle Management

Cross-Functional Collaboration

Strategic Planning

Phase 1-4 Studies

Specimen Data Delivery

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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