Job Description

Protocol Development: Draft and review clinical trial protocols according to regulatory guidelines, scientific principles, and sponsor specifications. Ensure protocols are clear, concise, and accurately reflect study objectives, endpoints, and methodology. Protocol Review and Approval: Collaborate with internal stakeholders including clinical operations, medical affairs, and regulatory affairs to review and finalize protocols. Incorporate feedback and revisions to ensure protocol integrity and alignment with study objectives. Scientific and Regulatory Compliance: Stay updated on ICH-GCP guidelines, regulatory requirements, and industry standards relevant to protocol development. Ensure protocols adhere to ethical standards and regulatory expectations for clinical research. Cross-functional Collaboration: Work closely with study teams, including Clinical Research Associates (CRAs), Data Managers, and Biostatisticians, to align on protocol development and implementation. Facilitate discussions and resolve protocol-related issues through effective communication and problem-solving. Documentation and Reporting: Maintain accurate documentation of protocol development processes, revisions, and approvals. Prepare and contribute to regulatory submissions related to protocol amendments and updates. Quality Assurance and Improvement: Conduct quality checks on protocols to ensure accuracy, consistency, and compliance with internal SOPs and industry best practices. Identify opportunities for protocol optimization and process improvements to enhance efficiency and quality. Qualifications and Skills Educational Background: Bachelors or Masters degree in Pharmacy (B.Pharm / M.Pharm) or Pharm D. Experience: 3-4 years of experience in clinical research, with a focus on protocol writing and development within the pharmaceutical or CRO industry. Proven track record of successfully developing clinical trial protocols and supporting regulatory submissions. Technical Skills: Strong understanding of clinical trial design, methodology, and regulatory requirements (ICH-GCP, FDA, EMA, etc.). Excellent scientific writing skills with the ability to convey complex information clearly and concisely. Communication and Collaboration: Effective interpersonal skills with the ability to collaborate across multidisciplinary teams. Proficiency in MS Office suite and familiarity with document management systems used in clinical research. Attention to Detail: Keen attention to detail and accuracy in protocol writing and documentation. Ability to manage multiple projects and deadlines while maintaining high-quality standards.

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