About This Role:The
Senior Clinical Study Manager is responsible for planning, executing, and overseeing clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory standards. This role involves collaborating with various stakeholders, including sponsors and regulatory authorities, to drive the successful completion of clinical studies. By managing the operational aspects of the trial, a Clinical Study Manager ensures that high-quality data is generated, contributing to the advancement of medical science and the development of new therapies.
What You Will Do: Study Management- Lead day-to-day management of study activities and deliverables.
- Serve as a liaison with stakeholders across all functional areas of the study.
- Manage study budget and timelines.
- Manage vendors, including the implementation and coordination of vendor scope of work (SOW).
- Serve as a point of contact for issue escalation.
- Interact directly with institutions and investigators, execute clinical research initiatives, and ensure alignment with strategic goals.
Study Start-Up, Site Management & Execution- Coordinate and support execution of study projects, including:
- Site identification and initiation
- Ethics and regulatory approvals
- Contracting
- Site budgeting and invoicing
- Site staff training
- Site initiations, routine monitoring, and close-out activities
- Identify and establish the suitability of study investigators and sites and liaise with them to ensure compliance with all study requirements, approvals, and agreements.
- Lead the development and implementation of key study documents, including study-specific plans, monitoring plans, study reference manuals, and source document templates.
- Lead the execution of clinical studies, evaluation and analysis of clinical data, and preparation/review of clinical study reports.
Quality, Compliance & Oversight- Oversee maintenance of clinical and regulatory files, ensuring accurate and timely tracking and documentation.
- Oversee the development of clinical reports supporting regulatory submissions.
- Oversee monitoring of study conduct and progress, including proactive identification and resolution of issues impacting quality, timelines, budget, or compliance.
- Identify and mitigate quality risks and/or issues associated with assigned studies and activities.
- Ensure study conduct complies with ethical and regulatory standards, SOPs, GCP, and local regulations.
Performance Tracking & Reporting- Lead the collection, tracking, and reporting of key performance indicators (KPIs), including:
- query resolution
- safety data collection/issues
- product/device reconciliation and shipment
- site and patient enrollment
- protocol deviations
Strategic & Business Support- Contribute to business development activities as a subject matter expert (SME).
- Generate strategy and proposal documentation as directed.
QualificationsRequired:- Bachelor's degree in health sciences or related discipline
- Minimum of 5 years of relevant experience in clinical study planning, preferably within a MedTech-oriented CRO
- Experience maintaining documentation in compliance with FDA and ISO standards
- Ability to independently manage multiple priorities in a fast-paced environment
- Strong organizational, analytical, and problem-solving skills
- Excellent written and verbal communication skill
