Team Lead/APM Clinical Research

As a Clinical Operations Manager at Novaspire, your role involves leading the operational planning and execution of Phase I-IV clinical trials across multiple therapeutic areas. You will be responsible for coordinating study start-up activities, managing CROs, vendors, and clinical sites, and ensuring timely delivery of study objectives. Your key responsibilities include: - Coordinating study start-up activities such as site selection, feasibility, contract negotiations, and ethics/regulatory submissions. - Developing and maintaining project timelines, budgets, risk mitigation strategies, and status reports. - Monitoring recruitment, data collection, protocol adherence, and query resolution across trial sites. - Supporting internal and external audits and inspections. - Overseeing documentation and archiving processes including Trial Master File (TMF) maintenance. - Participating in protocol development, clinical study report (CSR) preparation, and regulatory submissions. - Reviewing and approving CT-related SOPs and training materials. - Training the CT team, assessing, and retraining team members as required. Your qualifications for this role include: - Team Leadership and Training skills - Minimum 6 years Experience in Clinical Operations and managing Clinical Trials - Strong Research skills - Excellent communication and organizational skills - Ability to work effectively on-site in Bengaluru - Bachelor's or Master's degree in a relevant field - Experience in the pharmaceutical or biotechnology industry is a plus At Novaspire, we are committed to ensuring patient safety, regulatory compliance, and high-quality data to enhance clinical trial outcomes. Join us in our mission to deliver comprehensive, high-quality clinical research services to the pharmaceutical industry.,