Clinical Trial Manager I at ICON in Mumbai, Apply Now!
Looking to elevate your clinical research career? ICON is hiring a Clinical Trial Manager I in Mumbai, offering a dynamic opportunity to lead and manage global clinical trials at a world-renowned CRO. As a key player in clinical operations, you’ll coordinate local trial teams, ensure regulatory compliance, and contribute to groundbreaking research. Apply now to join a company where innovation meets impact.
About ICON:
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries. With a focus on innovation and excellence, ICON collaborates with clients to accelerate the development of drugs and devices that save lives and improve quality of life. Join our team and contribute to groundbreaking advancements in healthcare.
Clinical Trial Manager I at ICON
Location: Mumbai
Job Code: 2025-119406
Department: ICON Strategic Solutions Clinical Trial Management Office
About the Role:
Based on Regional or Country Practices official titles will vary for this level) Performs the role of Clinical Trial Manager (CTM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
Principle Relationships:
- Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial for Manager role.
- Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list.
- Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
- Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting for Manager role.
- Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
- Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress.
- Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
- May submit requests for vendor services and may support vendor selection
- May lead negotiation of trial site contracts and budgets, with the assistant from a CTM II or III. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting for Manager role.
- Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
- Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed
- Reviews and approves site and local vendor invoices as required
- Works with SM to ensure CAPP is implemented for audits and inspection or any quality related visits
- Complies with relevant training requirements.
- Acts as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
- Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
- Actively contributes to process improvement.
Principle Relationship:
- Reports to Functional Manager
- Internal Interfaces: Functional Manager, Partner with the CTAs, SMs, Quality & Compliance Managers/Experts, Contracts and Grants associates, GTM, R&D study team (e.g., SRP), protocol owners, data management and Medical Affairs (when applicable) to ensure overall trial coordination and site management activities for assigned protocols.
External Interfaces: Trial Site Personnel, external vendor representatives
Education and Experience Requirements:
- A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
- Specific therapeutic area experience may be required depending on the position. Should have basic understanding of the drug development process including ICH/GCP and local regulatory requirements.
- Solid communication and computer skills required.
- Proficient in speaking and writing the country language and English language. Good written and oral communication skills
Keywords: Clinical Trial Manager, ICON, Mumbai, Clinical Trial Management, Job Opening, Job Vacancy
