Career Opportunity: Clinical Trial Manager – SCP at Syneos Health

Syneos Health is inviting applications for the position of Clinical Trial Manager – SCP (Sponsored Dedicated / Client-Dedicated) based at its client office in Mumbai. The role is designed for seasoned clinical research professionals with strong background in onsite monitoring and therapeutic expertise in oncology.

Role Overview

Parameter	Details
Position	Clinical Trial Manager – SCP
Organization	Syneos Health (Clinical Solutions)
Location	Mumbai, Maharashtra (Client Office Based)
Experience Required	7+ Years of onsite clinical monitoring
Mandatory Domain	Solid Oncology clinical trial experience
Core Competencies	Site selection, initiation, routine monitoring, audit readiness, and closure

Key Responsibilities

Site Lifecycle Management: Conduct site qualification, initiation, routine interim monitoring, and study close-out visits (both onsite and remote) adhering to ICH-GCP, GPP, and protocol standards.
Ethics & Compliance: Confirm the validity of informed consent procedures, maintain subject confidentiality, and track protocol deviations or pharmacovigilance reports affecting patient safety or data integrity.
Data Verification & SDR: Execute Source Document Review (SDR) and Source Data Verification (SDV) on electronic data capture (EDC) systems; identify discrepancies and drive query resolution within study timelines.
Investigational Product (IP) Accountability: Supervise IP storage, temperature tracking, dispensing logs, reconciliation, and appropriate disposal or return according to blinded/unblinded requirements.
Documentation & TMF Alignment: Maintain the Investigator Site File (ISF) and reconcile records systematically with the Trial Master File (TMF); generate detailed trip reports, follow-up letters, and action trackers.
Cross-Functional Collaboration: Function as the primary liaison between trial sites, lead CRAs, sponsors, Medical Science Liaisons (MSLs), and country study managers to support subject recruitment and overall audit readiness.

Candidate Profile & Eligibility

Minimum 7 years of hands-on, onsite clinical trial monitoring experience within pharmaceutical, biotech, or global CRO settings.
Demonstrated hands-on management of complex clinical protocols in Oncology.
Thorough operational knowledge of global regulatory guidelines, ICH-GCP frameworks, and local Indian GCP guidelines.
Strong communication and problem-solving abilities to steer site activation and resolve clinical operational bottlenecks independently.