Global Trial Specialist

Location
Summit East, NJ, United States
Posted
Sep 17, 2020
Ref
R1529277
Required Education
Bachelors Degree
Position Type
Full time
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.

Objective
  • Contributes to the operational execution of clinical studies and supports complex global trials as needed.
  • Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.
  • Drives process / system enhancements related to GTS responsibilities / deliverables and manage / comply with various quality or compliance systems
  • Manages country planning, protocol level attributes and milestones/drivers in CTMS.
  • Manages the development and/or collection of study level documentation, support GTM in ensuring eTMF accuracy and completion for all studies.
  • Manages the global setup of study level non-clinical supplies.


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.


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 crossfunctionally, 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.