Clinical Trial Manager - SCP

Syneos Health, Inc.; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Syneos Health, Inc. in Mumbai seeks an experienced Clinical Research Associate (CRA) to oversee onsite monitoring with a focus on oncology.

The role covers site qualification, initiation, activation, and ongoing site management to ensure GCP, regulatory, and protocol compliance. The candidate will serve as the primary site contact, perform source data verification and ISF/TMF oversight, manage IP handling and documentation, and support risk assessment and query resolution both on-site and

Qualifications

• 7+ years of onsite clinical monitoring experience.
• Experience with site qualification, initiation and activation.
• Ability to act as primary point of contact for sites.
• Strong oncology experience required.
• Knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits (onsite or remote).
• Ensure regulatory, ICH-GCP and protocol compliance; escalate serious issues as needed.
• Verify informed consent documentation and protect subject confidentiality.
• Manage ISF and TMF, and ensure archiving per local guidelines.
• Conduct source data verification and data review, and drive query resolution to closure.
• Oversee IP inventory, labeling, import/release and storage compliance.
• Train and coordinate site staff to ensure trial progress within timelines.

Skills

Onsite monitoring

Site initiation

Site activation

Primary site contact

Oncology experience

GCP compliance

ISF/TMF oversight

Source data verification

IP handling

Query resolution

Tools

ISF management

Job description

Role & responsibilities :

• 7+ years of onsite clinical monitoring experience


• Good experience of Site selection, site initiation, and site activation


• Client Office based opportunity in Mumbai


• Should be able to act as the primary point of contact for sites


• Strong oncology experience is mandatory


• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiologic Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.


• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assess factors that might affect subject/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.


• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts 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 project 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 into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.


• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.


• May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.


• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.


• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.


• For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:
  Site support throughout the study lifecycle from site identification through close-out
  Knowledge of local requirements for real world late phase study designs
  Chart Abstraction activities and data collection

Preferred candidate profile :

Onsite monitoring experience is required.