Senior Clinical Study Manager

Veranex's mission as an Innovation CRO is to improve patient outcomes by accelerating our clients' innovations to market. As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

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.

Qualifications

Required:

• Bachelors 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

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.