Clinical Project Manager ( Pharmaceutical )

Job Description

Althera Laboratories India private Limited is a leading OSD (Oral Solid Dosage) manufacturing company committed to developing and delivering innovative pharmaceutical products. We are seeking a highly motivated and experienced Clinical Project Manager to lead and oversee clinical trials for our drug development pipeline. Role & responsibilities Develop and execute comprehensive clinical project plans, timelines, and budgets in alignment with company objectives and regulatory requirements. Oversee all aspects of clinical trial conduct, including protocol development, site selection, investigator initiation, patient recruitment, data management, and safety monitoring. Prepare and present clinical study reports, regulatory submissions, and other relevant documentation. Ensure adherence to Good Clinical Practice (GCP) guidelines, ICH regulations, and other relevant regulatory standards. Collaborate effectively with cross-functional teams, including R&D, regulatory affairs, quality assurance, and medical affairs, to achieve project milestones. Build and maintain strong relationships with key stakeholders, including investigators, CROs, and regulatory authorities. Monitor and manage project timelines, budgets, and resources effectively. Identify and mitigate project risks proactively. Proficiency in clinical trial management software and systems. Required Qualifications: M. Pharma/Ph.D Min. 8 to 12 years of experience in clinical project management within the pharmaceutical industry. In-depth knowledge of EU regulatory requirements for drug development and clinical trials Strong understanding of clinical research methodologies and statistical principles. Proactively manage project risks, develop mitigation strategies, and communicate effectively to project teams and management. Strong leadership and interpersonal skills with the ability to build and motivate cross-functional teams. Preferred Qualifications: - Experience in OSD product development and clinical trials. Knowledge of global regulatory requirements.