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NRDG Protocol Manager

Company: Bristol-Myers Squibb
Location: Princeton
Posted on: April 8, 2021

Job Description:

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 Protocol Manager will provide end-to-end project management of Non-Regulatory Data Generation (NRDG) clinical research. They will provide operational expertise and will focus on studies including Investigator Sponsored Research & other study types. Protocol managers act as a matrix leader for operational support team(s) and are accountable for the timely execution of NRDG trials. This position will support US ISR Trials.
-- Responsibilities:

  • Manages complex and varied study types across a matrix organization.
  • Familiar with clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality, timelines and budget are managed according to expectations.
  • Facilitates identification and prompt escalation of project risks and issues along with mitigation / resolution strategies to appropriate stakeholders and/or functional management, to expedite resolution. Proactively analyzes and drives efficient problem solving within team's control. Applies critical thinking to manage complex issues. Effectively leads team in collating information for operational reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items.
  • Experience in managing clinical components of vendor support and acts as a central point of contact for communication between the team and the external partners (e.g., CRO, networks, alliance partners etc.). Allows vendors autonomy in managing their assignments, while holding them accountable for deliverables. Ensures that tasks assigned to vendors are not duplicated by internal protocol/program team members.
  • Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables. Creates synergy with stakeholders and develops strong alliances and teamwork with Medical Monitor/Study Director, Operational leadership, field medical and other team members. Effectively leverages network of internal and external contacts. Requirements:
    • Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process. Strong understanding of GCPs, ICH and regulatory guidelines as they apply to protocol management and program strategy.
    • Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
    • Prefer individual with strong science background with a minimum of 5 years of demonstrated complex trial management experience in the pharmaceutical or CRO (or equivalent) industry 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.--
      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 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. W e're creatinginnovative 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.

Keywords: Bristol-Myers Squibb, Trenton , NRDG Protocol Manager, Executive , Princeton, New Jersey

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