Sr. Manager, Biospecimen Management at Bristol Myers Squibb

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biospecimen Management, Clinical Trials, Vendor Management, Data Management, Project Management, Stakeholder Management, Risk Management, Logistics, Problem Solving, Communication, Team Collaboration, Change Agility, Mentoring, GCP, GLP, CLIA

Industry

Pharmaceutical Manufacturing

Description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary Senior Manager, Biospecimen Lead is 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 and externally acquired biospecimens. Will develop and execute asset and protocol-level biospecimen strategies and work across the organization and with BMS’s 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 BMS’s continuous competitive advantage. Responsible for supporting biospecimen management for assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens Duties/Responsibilities Oversee and manage the complete lifecycle of biospecimens (collection, storage, use, and final disposition) for clinical studies with minimal to no supervision. Core Clinical Team member responsible for creating the Specimen Management Plan and facilitates discussions to operationalize strategy. 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 provide feedback. Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking with minimal Data Integration with enrollment and vendor specimen inventory. Able to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with minimal support. Able to identify biospecimen related risks with support from risk library as well as de novo. Manage Critical to Quality (C2Q) processes with clinical teams. Can identify and resolve vendor related issues in addition to vendor management responsibilities. Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and provide mitigation proposals to stakeholders. Prioritize BOW activities during critical deadlines with little or no supervision. Maintain advanced working knowledge of compound and study related biospecimen requirements. Seeks knowledge beyond own area of specialty. Reporting Relationship Reports to Associate Director/Director/Sr. Director, Biospecimen and Imaging Management, ICN & CP or HOCT Qualifications Specific Knowledge, Skills, Abilities: Deep knowledge of clinical biospecimen procedures and lifecycle including: collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired. Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Has developed Knowledge of the drug discovery or development process. Vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.). Makes decisions that require choosing between multiple options to resolve complex problems/issues. Ability to display skills for stakeholder management including conflict and change management. Actively participates and demonstrates the ability to independently manage projects and initiatives in addition to assigned BOW. Serves as SME/coach for junior staff to autonomously support trials. Plans, directs, and executes functional area processes for protocol related activities. Key participant in cross functional team meetings. Effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, without supervision. Demonstrates "Change Agility" by accepting new tasks and effectively working in multiple different operating models. Demonstrates inclusion by a) ready and willing source of information for CBI colleagues b) acting as mentor to colleagues b) active listening and gathering various points of views. Identifies issues and suggests solutions. Acts as CBI and GDO "ambassador" by exhibiting general knowledge of other GDO departments and responsibilities and willingly educates stakeholders. Minimum of 5-6 years academic, biotech, healthcare or pharmaceutical industry experience. Solid understanding of clinical and biomedical research including aspects such as: GCP, GLP, CLIA, data management, risk management, and regulatory issues. Experience preferred but not limited to: biospecimen life-cycle/operations, biospecimen result and data flows, compliance, management, and vendor management. Education/Experience/ Licenses/Certifications: Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience. Travel: Travel required is minimal, 0%- 5% of time, when required per study team request to support site training or vendor due diligence activities If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Responsibilities

Oversee and manage the complete lifecycle of biospecimens for clinical studies, including collection, storage, and final disposition. Develop and execute biospecimen strategies and manage vendor relationships to ensure timely delivery of specimen data.