Syneos Health is hiring for Central Monitor II and Senior Central Monitor I positions in Hyderabad. Both roles are full-time and based on a hybrid work model, with a focus on risk-based quality management, patient-level data review, clinical data analysis, safety signals, and site-level risk assessment.

Job Details

Positions

1. Central Monitor II

The Central Monitor II will review patient-level clinical data, identify risks and trends, assess patient safety and data integrity, and support clinical project teams through centralized monitoring activities.

2. Senior Central Monitor I

The Senior Central Monitor I will perform centralized monitoring activities, including review of patient and site data, KRI dashboards, metrics and reporting systems to identify risks, trends, data-quality issues and operational performance concerns.

Responsibilities

Key responsibilities across the two positions include:

• Review protocols and identify critical data, process, safety and data-integrity risks.
• Apply Risk-Based Quality Management (RBQM) principles to clinical monitoring activities.
• Review patient data listings, visualizations, analytical dashboards and reports.
• Confirm patient eligibility and identify protocol deviations, safety concerns and data-quality issues.
• Identify inaccurate, missing or illogical clinical data.
• Assess site-level factors affecting patient safety and clinical data integrity.
• Identify pharmacovigilance issues and escalate serious concerns to the project team.
• Develop action plans with appropriate guidance.
• Document observations and prepare queries, protocol deviations and action items.
• Maintain knowledge of ICH/GCP guidelines, applicable regulations and company SOPs.
• Review vendor systems and reports to verify IP dispensing and administration, laboratory procedures and other protocol-required activities.
• Verify that eTMF data is current and complete.
• Track and document monitoring activities according to SOPs and the Monitoring Plan.
• Manage assigned patient- and site-level activities within project timelines.
• Attend investigator and sponsor meetings, project staff meetings and required clinical training sessions.
• Assess site data quality, risks, trends and operational performance.
• Use KRI dashboards, metrics, reporting systems and analytical tools to synthesize findings and present actionable information to CRAs and other functional teams.

Eligibility / Qualifications

The supplied JD specifically requires knowledge and experience in:

• Risk-Based Quality Management (RBQM)
• Patient-level data review and analysis
• Data analytics
• Identification of risks, safety signals and efficacy trends

Required Skills

Candidates should have the ability to:

• Analyze patient-level clinical data.
• Review data through analytical dashboards and reports.
• Identify clinical and operational risks proactively.
• Recognize patient safety and data-integrity concerns.
• Identify protocol deviations and pharmacovigilance issues.
• Use KRI dashboards, metrics and reporting systems.
• Summarize complex data trends and findings clearly.
• Escalate serious issues appropriately.
• Adapt to changing project priorities.
• Work according to ICH/GCP requirements, applicable regulations and company SOPs.

Application Details

Application Link for Central Monitor II

Application Link for Senior Central Monitor I