Clinical Project Manager ( Pharmaceutical )

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.