Description

CTM I (SCP)

Job Responsibilities
- 7+ years of onsite clinical monitoring experience
- Good experience of Site selection, site initiation, and site activation
- Client Office based prospect in Mumbai
- Should be able to act as the primary point of contact for sites
- Strong oncology experience is mandatory
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assess site processes. Conduct Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.



Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data in

📌 CTM I (Pune)
🏢 Syneos Health
📍 Pune