Senior Clinical Trial Manager
Company: ICON plc
Locations: Bangalore / Chennai, India
Work Mode: Office or Home (Hybrid/Remote)
Department: Clinical Operations
Employment Type: Full-Time
Experience: 10+ years of experience in Clinical Research, including at least 4+ years in Clinical Trial Management within a CRO or Pharmaceutical organization. Experience in Global Clinical Trials (preferably EMEA region) and Clinical Monitoring is highly preferred.
Salary Package: ₹30–45 LPA (Approx., based on current market standards; final compensation depends on candidate experience, global trial management expertise, and leadership capabilities.)
Role Overview
The Senior Clinical Trial Manager is responsible for leading the clinical execution of global clinical trials from study start-up through database lock. The role oversees clinical operations, project budgets, study timelines, monitoring strategies, and cross-functional collaboration to ensure successful delivery of clinical studies while maintaining compliance with regulatory and quality standards.
Key Responsibilities
Clinical Trial Management
Lead the planning, execution, and oversight of global clinical trials.
Manage clinical trial activities from study start-up through database lock.
Ensure studies are delivered within agreed timelines, budgets, and quality standards.
Monitor overall study progress and proactively resolve operational challenges.
Study Start-up & Site Management
Lead study start-up activities to ensure timely site activation.
Drive patient enrollment and recruitment strategies.
Develop study monitoring plans and operational tools.
Support site management activities to ensure successful study execution.
Budget & Resource Management
Manage the clinical portion of project budgets.
Ensure efficient allocation and utilization of study resources.
Monitor project financial performance and support budget forecasting.
Identify and manage project risks that may impact cost or timelines.
Monitoring Oversight & Quality Management
Develop and implement monitoring strategies for clinical studies.
Review Clinical Research Associate (CRA) trip reports and monitoring activities.
Ensure protocol compliance, data integrity, and patient safety.
Implement Corrective and Preventive Actions (CAPA) when required.
Maintain inspection readiness throughout the clinical trial lifecycle.
Leadership & Team Development
Train, mentor, and support Clinical Research Associates (CRAs).
Provide guidance to Clinical Trial Managers (CTMs) and project teams.
Lead departmental initiatives and contribute to operational excellence.
Foster a collaborative and high-performing team environment.
Stakeholder & Vendor Management
Build and maintain strong relationships with:
Sponsors
Investigators
Vendors
Cross-functional teams
Serve as the primary clinical contact for assigned studies.
Facilitate communication across global project teams.
Ensure alignment of project goals and deliverables with stakeholders.
Risk Management & Compliance
Identify, assess, and mitigate clinical project risks.
Ensure compliance with:
ICH-GCP Guidelines
Global regulatory requirements
Company SOPs
Sponsor requirements
Support sponsor audits and regulatory inspections.
Ensure all clinical documentation is accurate, complete, and audit-ready.
Educational Qualification
Bachelor's degree in:
Life Sciences
Health Sciences
Pharmacy
Nursing
Biotechnology
Or another related discipline
Required Experience
10+ years of experience in Clinical Research.
Minimum 4+ years of experience in Clinical Trial Management within a CRO or Pharmaceutical organization.
Minimum 2+ years of Clinical Monitoring (CRA) experience is preferred.
Experience managing Global Clinical Trials, preferably in the EMEA region.
Experience managing complex, multicenter clinical studies.
Experience overseeing studies from start-up through database lock is preferred.
Experience mentoring CTMs and leading cross-functional teams is an advantage.
Technical Skills
Strong knowledge of:
Clinical Trial Management
Clinical Operations
Study Start-up
Patient Recruitment
Site Monitoring
Risk Management
Understanding of:
ICH-GCP Guidelines
Global regulatory requirements
Clinical trial budgeting
CAPA processes
Clinical project management
Proficiency in Clinical Trial Management Systems (CTMS), EDC platforms, and Microsoft Office Suite.
Experience managing global, multicenter clinical trials.
Key Competencies
Strong leadership and people management skills.
Excellent project and budget management abilities.
Strong analytical and decision-making capabilities.
Effective stakeholder and vendor management skills.
Excellent communication, negotiation, and presentation abilities.
Ability to manage multiple global clinical studies simultaneously.
High attention to quality, compliance, and operational excellence.
Strong organizational, planning, and risk management skills.
Ability to mentor teams and drive continuous improvement.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Green Way | Riga | Regulatory Labeling Manager (NA and LATAM Only) | Victoria | Remote - South America (Latin Americal) | Blue Bell | Tulsa | Ireland | Minnesota | Castlebar | French | Zaragoza | Perth | Remote - Middle East | Hammond | Bountiful | Bishop | Lenexa | Remote - Europe | Slovakia | Texas | Leinster | Xzagreb | Nairobi | Springville | Faridabad | Hungary | Medan | Switzerland | Thailand | Remote - Africa | Lousiana | Manipal | Milwaukee | Belgium | McFarland | Melbourne |Republic of Colombia :
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