Global Trial Specialist
- Bristol Myers Squibb
- 3 - 8 years
- Hyderabad
- 3 months ago
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Job Description
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.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: Research Associate / EngineerEmployement Type: Full timeContact Details:
Company: Bristol Myers SquibbLocation(s): Hyderabad+ View Contact
Keyskills: Payment processing Management systems Project management Clinical trials IRB Clinical research Project planning data privacy Operations Recruitment
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