Senior Global Trial Specialist

Bristol Myers Squibb

6 - 11 years

14 - 15 Lacs

hyderabad

Posted:-1 days ago| Platform:

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Skills Required

payment processing management systems project management clinical trials irb clinical research project planning data privacy operations recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Provides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies.
Uses performance metrics and quality indicators to assist the Global Trial Manager in driving study execution.
Proactively Identifies risks and develops/implements actions to avoid or mitigate.
Resolves routine problems and escalates important issues appropriately (with a sense of urgency).
Actively contributes as a key functional member on cross-functional teams.

Study/Project Planning, Conduct and Management

Provides and support input to study level tools and plans while working with moderate to minimal supervision.
Independently performs core GTS tasks and escalates/pushes back/delegates appropriately.
Actively contributes to study meetings by leading some components.
Contributes to oversight of the required country regulatory (e. g. , CTA, MoH) and country/site IRB/IEC approvals/notifications.
Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed.
Understands strategy and decision making at program level and their impact on the studies.
Ability to contribute to initiatives for process development and improvement.
Ability to assess a situation and identify path forward with the appropriate resources.
Understands interdependencies of tasks assigned.
Manages vendors and site payment processing and tracking.
Facilitate the maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports.

Qualifications:

Technical Competencies

Knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process.
Knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.
Working knowledge of project management preferred.

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