Clinical Trial Manager I / Ii

Syneos Health

4-8 years

preferred by company

PAN-India, India

Openings: 1 May 18, 2026

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines

Clinical Trial Manager I / II – Clinical Research Jobs in India | Client-Based Opportunity | Syneos Health

Location: Client-Based / India
Company: Syneos Health
Job Type: Full-Time
Work Mode: Client-Based / Field-Based / Hybrid as per project requirements
Department: Clinical Operations / Clinical Trial Management / Clinical Research
Experience Required: Typically 4–8+ years of relevant clinical research experience (based on role level and responsibilities)
Job ID: 25108578

About the Company

Syneos Health is a globally recognized clinical research organization (CRO) and biopharmaceutical solutions company that supports pharmaceutical, biotechnology, and healthcare innovators across the full drug development lifecycle. With strong expertise in clinical trial management, monitoring, regulatory compliance, site operations, and patient-focused research execution, Syneos Health offers exceptional growth opportunities for experienced clinical research professionals.

This opportunity is ideal for professionals seeking careers in clinical trial management, CRA leadership, site monitoring, GCP compliance, study execution, and sponsor-facing clinical operations.

Job Overview

Syneos Health is hiring a Clinical Trial Manager I / II for a client-based opportunity in India. This role is suited for experienced clinical research professionals with expertise in site monitoring, clinical trial execution, site management, regulatory compliance, patient safety oversight, and investigator site coordination.

The selected candidate will be responsible for overseeing site qualification, site initiation, monitoring visits, closeout activities, source document verification, trial documentation management, investigational product oversight, audit readiness, and clinical project delivery.

This role is ideal for professionals with CRA or clinical monitoring experience looking to move into broader clinical trial management responsibilities.

Key Responsibilities

Clinical Trial Monitoring & Site Management

Conduct:
- Site qualification visits
- Site initiation visits (SIV)
- Interim monitoring visits
- Remote monitoring activities
- Site closeout visits
Ensure compliance with:
- ICH-GCP guidelines
- Regulatory requirements
- Good Pharmacoepidemiological Practices (GPP)
- Sponsor protocols
- Internal SOPs
Evaluate site performance and recommend corrective actions where necessary.
Escalate critical site risks or compliance issues to project leadership.

Patient Safety & Regulatory Compliance

Verify informed consent documentation and compliance.
Protect patient confidentiality and subject rights.
Assess protocol deviations, pharmacovigilance concerns, and risks impacting patient safety or data integrity.
Ensure site-level compliance with regulatory expectations.

Clinical Data Review & Monitoring

Conduct Source Document Verification (SDV) and source document review.
Verify accuracy and completeness of clinical data entered into CRFs / EDC systems.
Drive query resolution to closure within project timelines.
Support remote and on-site clinical data review processes.

Investigational Product (IP) Oversight

Review investigational product inventory, reconciliation, storage, and accountability.
Verify correct dispensing and protocol-compliant administration.
Monitor blinded/randomized study processes where applicable.
Ensure compliance with labeling, import, release, and return procedures.

Trial Documentation Management

Maintain and reconcile:
- Investigator Site File (ISF)
- Trial Master File (TMF)
- Monitoring reports
- Follow-up letters
- Communication logs
- Study documentation records
Ensure audit-ready documentation standards.
Support essential document archival requirements.

Study Coordination & Site Support

Serve as a primary liaison between sites, sponsors, and project teams.
Support investigator meetings, sponsor meetings, and project reviews.
Ensure study teams and sites are properly trained.
Support recruitment, retention, and patient awareness initiatives.

Project Delivery & Operational Oversight

Manage site-level timelines, communication, deliverables, and operational priorities.
Support study budgets, timelines, and project milestone achievement.
Adapt to changing clinical priorities under project leadership guidance.

Audit Readiness & Quality Assurance

Prepare sites for audits and inspections.
Support follow-up actions and compliance remediation.
Promote continuous quality improvement across clinical trial execution.

Real World Late Phase Study Support (Where Applicable)

Support site lifecycle management from identification to closeout.
Assist with chart abstraction and real-world data collection.
Collaborate with sponsor affiliates, medical science liaisons, and local teams.

Required Qualifications

Bachelor’s degree in:
- Life Sciences
- Pharmacy
- Biotechnology
- Nursing (RN)
- Clinical Research
- Medicine
- Related healthcare disciplines
Equivalent combination of education, training, and clinical experience may be considered
Strong knowledge of:
- ICH-GCP
- Clinical monitoring
- Regulatory compliance
- Clinical trial documentation
- Site management
- EDC / CRF systems
- Investigational product accountability
Strong computer literacy and ability to work with clinical technologies
Excellent communication, presentation, and stakeholder management skills

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Clinical Trial Manager I / Ii

Job Description

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