PHARMAFull-time
Clinical Trial Manager - SCP
By Admin · Clinical Research & Clinical Operations
MUMBAI (IN)ONSITEPOSTED: 9/16/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE OVERVIEW
Clinical Trial Manager role supporting clinical trial site management and monitoring activities, with a mandatory oncology focus and 7+ years of onsite clinical monitoring experience. The role is client-office based in Mumbai and involves end-to-end site oversight, compliance, documentation and stakeholder coordination.
ROLE DEFINITION & RESPONSIBILITIES
- •Perform site qualification, site initiation, interim monitoring, site management and close-out visits
- •Act as primary point of contact for assigned clinical trial sites
- •Assess site performance and recommend site-specific actions
- •Verify informed consent, patient safety and clinical data integrity
- •Conduct source document review and verify CRF data accuracy and completeness
- •Drive query resolution and verify electronic data capture compliance
- •Manage investigational product inventory, reconciliation, storage and dispensing compliance
- •Review Investigator Site Files and reconcile them with the Trial Master File
- •Prepare monitoring reports, follow-up letters, trip reports and communication logs
- •Support patient recruitment, retention and awareness strategies
- •Manage site-level scope, budgets, timelines and communications
- •Support audit readiness and Investigator Meetings
- •Train site and project-specific personnel and ensure compliance
Reporting Hierarchy: Reports to the Lead CRA/project clinical operations leadership; Acts as primary liaison with site personnel and collaborates with CRAs or Central Monitoring Associates as required; Exact team size not specified
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 7+ years of onsite clinical monitoring experience
- Strong oncology experience is mandatory
- Experience with site selection, site initiation and site activation
- Knowledge of ICH-GCP and applicable regulations
- Experience with site management and clinical monitoring activities
- Ability to act as primary site contact
PREFERRED QUALIFICATIONS
- •Experience with real-world late-phase studies
- •Chart abstraction and data collection
- •Collaboration with sponsor affiliates, medical science liaisons and local country teams
- •Experience with audit preparation and inspection readiness
- •Experience with CTMS/electronic data capture systems
REQUIRED VERIFIED SKILLS
Clinical monitoring
oncology
site selection
site initiation
site activation
site management
close-out visits
ICH-GCP
GPP
protocol compliance
informed consent
source document review
CRF
query management
pharmacovigilance
IP management
ISF
TMF
audit readiness
clinical trial documentation
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression, supportive line management, technical and therapeutic-area training, peer recognition and total rewards programs
The source posting does not disclose specific salary figures or bonus/equity amounts. It references total rewards and performance-related employment benefits without numerical compensation details.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a global, fully integrated life sciences services organization supporting customers across the drug development and commercialization continuum.
TEAM SIZE: 25,000+ colleagues
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Agile, collaborative and inclusive environment focused on drug development, customer delivery, career development and patient impact.
EXPECTED CAREER ROADMAP
Potential progression can include senior clinical operations, Lead CRA, Clinical Trial Manager leadership and broader study/project management positions, depending on experience and organizational opportunities.
APPLICATION ADVISORY
Emphasize 7+ years of onsite clinical monitoring experience and mandatory oncology expertise; clearly demonstrate site selection, initiation and activation experience; highlight ICH-GCP and regulatory compliance; include examples of monitoring, source document review, query resolution, IP accountability and audit readiness; tailor the resume to client-office and site-management responsibilities.
RECOMMENDED TRAINING
1/5
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