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2 Bristol-Myers Squibb Specialist Jobs

Senior Global Trial Specialist

3-5 years

Hyderabad / Secunderabad

1 vacancy

Senior Global Trial Specialist

Bristol-Myers Squibb

posted 5d ago

Job Role Insights

Flexible timing

Job Description


Title/Role - Senior Global Trial Specialist
Job Description
Position Summary
Contributes to the operational execution of clinical studies to ensure delivery
on time, within budget, and of high quality in compliance with ICH/GCP,
Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs.
Participates on one or more cross-functional study team(s) and/or performance
and quality oversight of one or more Contract Research Organization (CRO)
teams and vendors.
Primarily works on routine to complex projects/trials at varying stages and
supports multiple complex trials as needed.
Contributes to achieving corporate and study team goals, successfully
completes assigned tasks, participates in service provider oversight, and sets
priorities with guidance.
Proactively manages multiple assignments and operational processes with
moderate to minimal supervision.
Has high functional impact on the study team and the organization.
Disclaimer: The responsibilities listed above are only a summary and other
responsibilities will be requirements as assigned.
Duties/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:
Project Management
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.
  • Reporting Relationship Crossing all therapeutic areas and research phases, collaborate with cross[1]functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.
Qualifications Specific Knowledge, Skills, Abilities:
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.
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.
Acts as a role model in supporting change within the organization and
has knowledge of cross-functional partners who can help clarify change.
Mentors and coaches other team members and GTS , as appropriate,
and participate or provide leadership in departmental initiatives.
Builds relationships to achieve influence with others.
Develops and maintains collaborative relationships with internal and
external stakeholders to be more effective in the role.
Displays a willingness to challenge the status quo and take risks.
Effective oral/written communication and presentation skills, ability to
collaborate with key stakeholders and across the organization.
Education/Experience/ Licenses/Certifications:
BA/BS in relevant discipline strongly preferred.
Minimum 1 years experience in Clinical Research or related work
experience.
Experience in the use of industry Clinical Trial Management Systems and
Clinical Trial Master File Systems.
Travel required less than 5%.
accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

Employment Type: Full Time, Permanent

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What Specialist at Bristol-Myers Squibb are saying

Specialist salary at Bristol-Myers Squibb

reported by 2 employees with 2-3 years exp.
₹8.4 L/yr - ₹10.7 L/yr
7% less than the average Specialist Salary in India
View more details

What Bristol-Myers Squibb employees are saying about work life

based on 120 employees
90%
81%
51%
86%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Bristol-Myers Squibb Benefits

Soft Skill Training
Cafeteria
Health Insurance
Team Outings
Job Training
Work From Home +6 more
View more benefits

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