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Senior Global Trial Lead

Bristol Myers Squibb
0-2 years
INR 30-55 LPA
Hyderabad
10 June 15, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Position Summary

The Clinical Trial Manager (CTM) is responsible for leading and overseeing global clinical trials from study start-up through close-out. The role ensures studies are delivered on time, within budget, and in compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards.

The position requires leadership of cross-functional global teams, vendor oversight, budget management, risk mitigation, and strategic operational planning across multiple international clinical studies.


Key Responsibilities

Project Management

  • Lead collaboration with internal study teams and external vendors.

  • Ensure clinical trial delivery meets timelines, budgets, and quality standards.

  • Provide strategic input into study feasibility and operational planning.

  • Manage study risks and develop mitigation strategies.

  • Balance cost, timelines, quality, and operational priorities.

  • Monitor study performance metrics and KPIs.

  • Establish and maintain project management tools, including:

    • Risk Registers

    • Action Logs

    • Issue Trackers

    • Decision Logs

  • Develop and implement global operational best practices.


Vendor & CRO Management

  • Manage CROs and external vendor relationships.

  • Participate in vendor selection and qualification activities.

  • Oversee vendor contracts and Statements of Work (SOW).

  • Review and approve:

    • Vendor invoices

    • Budget accruals

    • Change orders

    • Scope amendments

  • Ensure vendors meet performance and quality expectations.


Study Strategy & Operational Leadership

  • Provide therapeutic and operational guidance for clinical studies.

  • Support study teams with risk management and execution strategies.

  • Advise teams on emerging clinical operations trends.

  • Drive operational excellence across programs.

  • Mentor and coach study team members and junior staff.


Budget & Resource Management

  • Lead study budget planning and forecasting.

  • Monitor financial performance throughout the study lifecycle.

  • Conduct quarterly budget reviews.

  • Identify budget variances and implement corrective actions.

  • Collaborate with Finance for forecasting and resource allocation.

  • Manage vendor and study-related expenditures.


Study Oversight & Execution

  • Provide end-to-end oversight from study start-up through close-out.

  • Lead global cross-functional study teams.

  • Coordinate with:

    • Clinical Research

    • Medical Affairs

    • Regulatory Affairs

    • Data Management

    • Biostatistics

    • Pharmacovigilance

  • Monitor operational metrics and study performance.

  • Ensure alignment with overall development and franchise strategies.

  • Resolve operational challenges impacting study execution.


Systems & Data Management

  • Maintain accurate study records in:

    • Veeva CTMS

    • Veeva eTMF

    • Clinical Trial Management Systems

  • Track study milestones and deliverables.

  • Ensure data quality and system compliance.

  • Support operational reporting and decision-making.


Required Qualifications

Education

  • Bachelor's Degree (BA/BS) in:

    • Life Sciences

    • Pharmacy

    • Biotechnology

    • Clinical Research

    • Healthcare-related discipline

  • Advanced Degree preferred.


Experience

Required

  • Minimum 6 years of Clinical Operations experience.

  • Experience managing complex global clinical trials.

  • Experience working within multinational pharmaceutical or biotech organizations.

  • Experience leading cross-functional teams.

Preferred

  • CRO management experience.

  • Global trial leadership experience.

  • Program-level clinical operations exposure.


Technical Competencies

Global Trial Management

  • Clinical Trial Planning

  • Study Execution

  • Global Study Oversight

  • Project Lifecycle Management

Clinical Operations

  • Site Selection

  • Patient Recruitment

  • Study Monitoring Oversight

  • Clinical Trial Governance

Financial Management

  • Budget Forecasting

  • Vendor Payments

  • Accrual Management

  • Cost Control

Regulatory Knowledge

  • ICH-GCP Guidelines

  • Global Regulatory Requirements

  • Audit Readiness

  • Inspection Preparedness

Systems Expertise

  • Veeva CTMS

  • Veeva eTMF

  • Clinical Trial Management Systems

  • Trial Performance Dashboards


Leadership Competencies

Leadership & Collaboration

  • Lead global matrix teams.

  • Influence stakeholders without direct authority.

  • Build strong cross-functional partnerships.

Decision Making

  • Analyze complex situations.

  • Make data-driven operational decisions.

  • Prioritize patient safety and study quality.

Accountability

  • Own study outcomes.

  • Deliver projects within scope, budget, and timeline.

Communication

  • Present to senior leadership.

  • Communicate effectively with global stakeholders.

  • Manage escalations professionally.

Adaptability

  • Manage organizational change.

  • Navigate complex global environments.

  • Resolve conflicts constructively.


Travel Requirement

  • Up to 25% international and domestic travel.


Career Progression

Potential future roles include:

  • Senior Clinical Trial Manager

  • Global Trial Lead (GTL)

  • Associate Director, Clinical Operations

  • Director, Clinical Operations

  • Program Lead

  • Development Operations Lead