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Job Details


Bristol Myers Squibb

Trial Specialist, NRDG (R1557992-en-us)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Princeton, New Jersey, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Trial Specialist, Late Development is responsible for providing end-to-end management of Late Development research, including Company-sponsored Non-Interventional Research (NIR), Investigator-Sponsored Research (ISR), Pre-approval Access Programs (PAA), and some local late-phase interventional research in the United States.

Purpose/Objective of the Job:

  • Supports successful and timely operational execution of Late Development research (BMS sponsored late phase, non-interventional research (NIS), ISRs, PAA)
  • Supports project management concepts to manage issues, risks, and timelines
  • Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams
  • Drives process / system enhancements related to TS responsibilities / deliverables and manage / comply with various quality or compliance systems

Key Responsibilities and Major Duties:

  • Focus on local level projects including local country studies.
  • Study & Project Planning, Conduct and Management
  • Manages country planning, protocol level attributes and milestones/drivers in CTMS.
  • Manages the development and/or collection of study level documentation, support Trial Manager in ensuring eTMF accuracy and completion for all studies.
  • Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.
  • Raises possible issues for potential escalation to the appropriate colleagues.
  • Follows instructions, determines level of understanding, and seeks clarification when needed.
  • Facilitation of fund management and payments in collaboration with respective stakeholders
  • Ensure payment processing and reconciliation
  • Manage trial documents and data for the Trial Managers within given Hub/Region
  • Cross functional engagement with various Stakeholders

Minimum Requirements:

  • BA/BS or associates degree in relevant discipline
  • 1-3 years’ experience in Clinical Research or related work experience. Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems.
  • Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.
  • Knowledge of ICH/GCP, regulatory guidelines/directives, and the drug development process
  • Basic understanding of project management desired.
  • Proficient in Microsoft Word, Excel and PowerPoint.
  • Displays a willingness to challenge the status quo and take risks.
  • Effective oral and written communication skills, ability to influence cross-functionally, demonstration of leadership capabilities.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.