Team Lead / APM Clinical Research

Company Description

At Novaspire, we pride ourselves on being a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We support pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the product development lifecycle, from Phase I clinical studies to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services and training, and imaging studies. We are committed to ensuring patient safety, regulatory compliance, and high-quality data to enhance clinical trial outcomes.

Role Description

• Lead the operational planning and execution of Project
• Phase I-IV clinical trials across multiple therapeutic areas.
• Coordinate study start-up activities including site selection, feasibility, contract negotiations, and ethics / regulatory submissions.
• Manage CROs, vendors, and clinical sites to ensure timely delivery of study objectives.
• Develop and maintain project timelines, budgets, risk mitigation strategies, and status reports.
• Ensure that all trial documentation (protocols, CRFs, ICFs, etc.) meets regulatory and scientific standards.
• Monitor recruitment, data collection, protocol adherence, and query resolution across trial sites.
• Support internal and external audits and inspections.
• Oversee documentation and archiving processes including Trial Master File (TMF) maintenance.
• Participate in protocol development, clinical study report (CSR) preparation, and regulatory submissions.
• Review and approve CT-related SOPs and training materials.

Train the CT team, assess, and retrain the team members of Novaspire as required.

Qualifications

Skills Required

Risk Mitigation, Regulatory Submissions, Training, clinical operations , Team Leadership, Clinical Trials