Global Trial Associate (Bristol Myers Squibb)

Roles and Responsibilities

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.

Qualifications:

Technical Competencies

• Basic knowledge of clinical research budgets including processing, reporting and tracking of vendor payments is a plus.

• Knowledge of ICH/GCP and regulatory guidelines/directives.

• Basic understanding of project management is 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/written communication skills, ability to collaborate with key stakeholders and across the organization.

Education/Experience:

• BA/BS or Associate degrees in relevant discipline

• 3+ years experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is preferred.

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

• Global experience is a plus.

• Travel required less than 5%.