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Ctm I / Ctm Ii – Clinical Trial Management & Clinical Operations

Syneos Health
Syneos Health
2+ years
preferred by company
Remote, India, India
1 May 11, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

CTM I / CTM II – Clinical Trial Management & Clinical Operations

Company: Syneos Health
Job Title: CTM I / CTM II
Location: Remote – India
Job ID: 25107742
Department: Clinical Operations / Clinical Trial Management


About the Role

Syneos Health is hiring a Clinical Trial Manager (CTM I / CTM II) for its Clinical Operations team. This remote opportunity is ideal for professionals experienced in Clinical Trial Management, Site Management, Clinical Monitoring, Vendor Management, Risk-Based Monitoring, and Clinical Operations Leadership.

The selected candidate will oversee site management, clinical monitoring, central monitoring activities, patient safety compliance, risk management, and study execution across global clinical trials.

This opportunity is best suited for candidates with minimum 2 years of CTM experience and prior clinical trial management expertise.


Key Responsibilities

Clinical Trial Management & Site Oversight

  • Lead and oversee:
    • Site management activities
    • Clinical monitoring deliverables
    • Central monitoring operations
  • Ensure compliance with:
    • ICH-GCP Guidelines
    • Regulatory requirements
    • Study protocols
    • Monitoring plans
  • Manage site interactions from activation through close-out
  • Support:
    • Patient recruitment activities
    • Investigator payments
    • Study milestone tracking

Risk Management & Study Oversight

  • Identify critical data and protocol execution risks
  • Support Risk Assessment and Categorization Tool (RACT) activities
  • Use operational metrics and reports to identify study risks
  • Escalate timeline, quality, or budget-related concerns to project leadership
  • Develop and implement risk mitigation strategies

Cross-Functional Collaboration

  • Collaborate with:
    • Clinical Monitoring teams
    • Data Management
    • Study Start-Up teams
    • Patient Recruitment teams
    • Pharmacovigilance
    • Quality Assurance (QA)
  • Coordinate study deliverables and operational handoffs
  • Support:
    • Site activation targets
    • Enrollment milestones
    • Database lock timelines

Clinical Systems & Documentation Management

  • Develop and maintain:
    • Clinical Monitoring Plans (CMP)
    • Study tools and templates
    • Site management documentation
  • Ensure systems are configured and available for study teams, including:
    • CTMS
    • EDC
    • eDiary
    • ePRO
    • TMF
    • IVRS/IWRS
    • Central Monitoring Dashboards
  • Oversee user acceptance testing (UAT) and audit trail reviews

Clinical Monitoring Oversight

  • Review:
    • Site visit reports
    • Site letters
    • Central monitoring reports
    • Monitoring documentation
  • Ensure monitoring deliverables reflect:
    • Protocol compliance
    • Patient safety
    • Data integrity
    • Site management quality
  • Ensure documentation quality and timely delivery according to sponsor requirements

Training, Leadership & Team Coordination

  • Coordinate protocol-specific and operational training activities
  • Oversee:
    • CRA and Central Monitor allocations
    • Site assignments
    • Study team compliance
  • Provide performance feedback to line managers
  • Support mentoring and operational guidance for clinical teams

Stakeholder & Client Management

  • Participate in:
    • Kick-Off Meetings
    • Sponsor meetings
    • Study management discussions
  • Act as escalation point for investigator site communication
  • Provide operational updates and risk assessments to clients and leadership
  • Support Requests for Proposals (RFPs), budgeting, and bid defense activities

Educational Qualification

Candidates should possess:

  • Bachelor’s Degree in a healthcare or life sciences field
    OR
  • Registered Nurse (RN) qualification
    OR
  • Equivalent combination of education, training, and clinical research experience

Required Experience

Mandatory Experience

  • Minimum 2+ years of CTM experience
  • Prior experience in:
    • Site management
    • Clinical trial operations
    • Clinical monitoring

Preferred Experience

  • Vendor management experience
  • Risk-based monitoring
  • Central monitoring activities
  • Budget and project management exposure