Job Summary LTM is responsible and accountable for deliverables of studies assigned to RCO unit performing end to end study related onsite remote monitoring quality data review essential documents management for studies managed in-house with-in agreed timelines budget and desired quality standards LTM is expected to adhere to required standard operating procedures regulatory requirements ICH GCP and quality in compliance with Sun Procedural Documents Area Of Responsibility Ensures clinical trials are conducted at assigned sites as per protocol local regulatory requirements ICH GCP ensure data integrity patient safety and trials are conducted as per ethical standards declaration of Helsinki Act as primary communication point between SPIL and clinical trial site w r t site management activities Facilitating regulatory submission Train and Mentor CRA s as applicable Support RTL s on trial management tasks as delegated Perform Accompanied site visits with CRA s where required and applicable Take part in Quality Oversight activities as assigned by RTL s Perform site feasibilities ensure site database is updated on periodic basis with feasibility results Identify plan and conduct Site Selection visits ensure actions from SSV s are followed up with the assigned team Planning and performing IRB submissions in an effective manner to secure timely approvals ensure IRB IEC dossiers are prepared and submitted as per site IEC requirements Review of the Translated documents of the study Negotiating study budgets with sites ensure Clinical Trial Agreements are executed in timely manner Ensure timely processing of the site invoices per the executed CTA and tracking all the site related payments during the conduct of the studies assigned Ensure the site related details are correctly timely updated in the essential systems for assigned studies For e g Contact details of site PI HOI IEC Responsible to perform SIV and training to the study team Ensure the sites are regularly trained on

📌 Local Trial Manager (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram