Manager, Biospecimen Operations Lead

Year    Hyderabad, Telangana, India

Job 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 rich in diversity. 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. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Functional Area Description
Support the strategic and tactical planning as well as operational management of biospecimens, which contribute to asset development. Our functional teams ensure timely availability of high quality, accurate, biological specimens; along with managing biospecimen information-driven by end-to-end visibility and best in class logistics. Position Summary This role is 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. 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 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. The individual will be responsible for supporting biospecimen management for the Full and Late 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 (collection, use, and disposal) for full and late phase clinical studies with minimal supervision. Core Clinical Team member responsible for creating the Specimen Management Plan and facilitates discussions to operationalize strategy with minimal supervision. Provide 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 Degree Requirements
Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience. Experience Requirements Minimum of 2 years academic, biotech, healthcare or pharmaceutical industry experience. 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, sample management, and vendor management. Key Competency Requirements Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Vendor experience (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 Planning and/or 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. Demonstrates change Agility through willingness to pivot current ways to working to new model(s)
#HYDDD 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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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Job Detail

  • Job Id
    JD3074397
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year