Sr.ClinicalStudiesAssociate

Job Summary The Senior Clinical Studies Associate supports the planning, execution and oversight of clinical studies throughout the study lifecycle. Working under the guidance of Clinical Study Manager and cross-functional study teams, the SCSA contributes to study operations, documentation, regulatory compliance, and process improvement initiatives. This role requires strong organizational skills, attention to detail, ability to coordinate effectively with stakeholders to ensure successful study execution and adherence to quality standards. ## Requirements Essential Duties and Responsibilities Clinical Study Execution & Coordination * Support the planning, execution, and day-to-day management of clinical studies and projects. * Develop study timelines, milestones, and project tracking tools. * Coordinate study meetings, prepare agenda, document meeting minutes, and track action items to completion * Facilitate communication among cross-=functional teams, investigators, CROs and internal and external stakeholders * Support study startup, maintenance and closeout activities. * Identify and escalate routine study issues, risks, or delays as appropriate. Clinical Documentation & Compliance * Draft, update, and maintain clinical study documentation in accordance with regulatory requirements, GCP guidelines and company procedures. * Support the development, review, and completeness of study documents, including protocols, study plans, and essential documents for regulatory submissions. * Conduct routine clinical data reviews and support data quality activities. * Ensure timely filing, quality review, and completeness of Trial Master File (TMF) documentation. * Assist with development and validation of case report form (CRF), and data validation activities, including associated training and documentation. * Maintain study records and controlled documentation in accordance with quality system requirements and document control procedures. * Support audit and inspection read