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Global Trial Specialist

Company: Bristol Myers Squibb
Location: Princeton
Posted on: June 12, 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.

Responsibilities involve a combination of execution and oversight, dependent on

the sourcing model, to ensure deliverables and may include, but are not limited to, the following:

Study/Project Planning, Conduct and Management

  • Understands study level tools and plans.
  • Provides support to the GTM along with the appropriate teams for response

to country/regulatory and IRB/IEC.

  • Provides operational input and participates in operational processes in

support of the startup maintenance and close out of studies.

  • Assist the GTM in driving study execution.
  • Learns, observes and performs core GTS tasks and escalates appropriately.
  • 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.

  • Seeks guidance to navigate undefined tasks, challenges, and study

tools/resources.

  • Develops, updates, and submits Transfer of Obligations to Regulatory

Authorities.

  • Manages global vendor site lists and resolve issues related to global site lists.
  • Manages study mail-groups/distributions and SharePoint/Study Directory

updates.

  • Participates, sets up agendas, and captures meeting minutes in study team

meetings for assigned protocols.

  • Identifies issues and risks, develops mitigations, and escalates appropriately.
  • Participates in filing activities and any associated audits as applicable.

Degree Requirements

  • BA/BS or Associate degrees in relevant discipline

Experience Requirements

  • Experience in the use of industry Clinical Trial Management Systems and

Clinical Trial Master File Systems is a plus.

  • Experience in Clinical Research or related work experience.
  • Global experience is a plus.

Key Competency

Requirements

Technical Competencies

  • Basic knowledge of clinical research budgets including processing and tracking

of site and vendor payments is preferred.

  • Knowledge of ICH/GCP and regulatory guidelines/directives.
  • Basic understanding of project management desired.

Management Competencies

  • Begin to network and foster relationships with key stakeholders across the

study team.

  • Responds flexibly to changing business demands and opportunities,

proactively looking for ways to contribute.

  • 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.

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.

Keywords: Bristol Myers Squibb, Trenton , Global Trial Specialist, Other , Princeton, New Jersey

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