Local Trial Manager

As a Lead Trial Manager (LTM) at the RCO unit, you will be responsible for the successful delivery of studies assigned to you. Your role will involve performing end-to-end study-related onsite and remote monitoring, ensuring quality data review, and managing essential documents for in-house studies within agreed timelines, budget, and quality standards. Your key responsibilities will include: - Ensuring that clinical trials are conducted at assigned sites in compliance with the protocol, local regulatory requirements, ICH GCP, and ethical standards - Acting as the primary communication point between SPIL and clinical trial sites for site management activities - Facilitating regulatory submissions and IRB approvals - Training and mentoring CRAs - Supporting RTLs on trial management tasks - Performing accompanied site visits with CRAs as needed - Conducting site feasibilities and site selection visits - Negotiating study budgets with sites and ensuring timely execution of Clinical Trial Agreements - Planning and conducting onsite monitoring visits and ensuring timely follow-up on action items - Providing updates to RTLs and management on study progress, risks, and quality - Collaborating with cross-functional units to ensure efficient study conduct - Managing IMP and study protocol required supplies at sites - Tracking recruitment and retention strategies and communicating recruitment risks proactively - Ensuring compliance with onsite visits, reporting requirements, and DBL requirements - Preparing sites for audits, inspections, and overseeing visits - Reviewing and filing essential documents in ITF and TMF - Coordinating with PI/site team for study conduct obligations - Maintaining effective communication with the site team and escalating compliance issues as needed - Playing an active role in planning and managing Investigator meetings For outsourced trials, you will be required to: - Conduct accompanied visits with CRO monitors to ensure quality, PI oversight, and site management - Share observations of accompanied visits with CRO-CRA post-visit and ensure actions are followed up until closure In terms of qualifications, you should be a minimum Pharmacy Graduate (04 Years) or Post Graduate in pharmacy or other science/healthcare fields. Added qualifications will be preferred. Additionally, you should have at least 5 years of experience in the clinical research field and at least 3-4 years of onsite monitoring experience for Phase II/III global clinical trials. In this role, you will be operating within the India Cluster and the position is full-time with frequent travel requirements.,