Job Description

Department
PTC - MORAIYA
Job posted on
Dec 16, 2025
Employment type
P-P6-Probationer-R&D Executive

Organize and evaluate objectives for Clinical studies during development of Generic Products, including ANDA and 505(b)(2) filings. Coordinate with CROs for patient-based clinical studies in different Phases, ensuring that all aspects of the study are meticulously planned and completed. Implement Clinical Trial protocols to ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines. Develop and review study-related documents, including study plans, investigator files and informed consent documents Function as Study Monitor for clinical trial, ensuring it is conducted and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and other applicable regulatory requirements. Review invoices from study vendors, clinical study agreements and monitoring reports Collaborate with CROs, Investigators and Clinical Operation teams for smooth communication and coordination for study conduct. Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation Track study progress and ensure alignment with project milestones, client deliverables, and budgets, providing regular updates to stakeholders Review study updates and reports, including detailed analysis of study data
Assignments may include other non-trial related activities such as interaction with Formulation and Project Management teams.
Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions * Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability