Pharm'Up 
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.
About the Author
