Clinical Project Manager

Role Overview: As a Clinical Project Manager, you will be responsible for proactively managing clinical trials from start-up to closure, ensuring focus on trial timelines, quality, budget, and vendor oversight. Your role will involve leading the selection of CRO and vendors, supporting the preparation of regulatory dossier, overseeing the study start-up process, collaborating with the Clinical Trial Supply Management function, monitoring the quality of vendor deliverables, and ensuring high-quality trial execution at sites. Key Responsibilities: - Manage clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight. - Lead the selection of CRO and vendors, including identification, RFP process, qualification, and contract negotiation. - Support the preparation of regulatory dossier by providing documents and required information. - Lead the study start-up process, including preparation of trial kick-off meeting, study documents, plans and manuals, set-up of the trial master file (TMF), and site feasibility process. - Collaborate with Clinical Trial Supply Management function to ensure effective procurement and supply strategy for study medication. - Oversee CRO and vendors during the trial to ensure compliance with project requirements, timelines, budget, and quality standards. - Monitor the quality of vendor deliverables, address quality issues, and identify opportunities for improvement. - Ensure study is inspection ready at all times. - Provide updates on trial progress to Head of Clinical Operations and Senior Management. - Ensure trials are registered in trial registries, accuracy of trial information, and timely submission of updates and final reporting. - Ensure timely shipment and tracking of lab samples to ensure no loss due to lack of operational oversight. - Support vendor and site audits, follow up on findings, and ensure appropriate responses and CAPAs are implemented. - Ensure all project-level study documentation is filed in the TMF in accordance with SOPs and regulatory requirements. - Support preparation of responses to queries from Regulatory, Marketing, or other molecule-related queries. - Ensure completion and archiving of eTMF, budget reconciliation, and retention or disposal of lab samples and IMP samples. - Support SOP development and review, participate in process improvement activities, and other necessary tasks. Qualifications Required: - Bachelor's degree in a related field (e.g., life sciences, pharmacy, nursing) required; advanced degree (e.g., Master's, PhD) preferred. - Minimum of X years of experience in clinical project management within the pharmaceutical or biotech industry. - Strong knowledge of ICH GCP guidelines, clinical trial processes, and regulatory requirements. - Excellent communication, organizational, and leadership skills. - Ability to work effectively in a fast-paced environment and manage multiple priorities. - Proficiency in MS Office and project management software. - Certification in project management (e.g., PMP) is a plus.,