Clinical Operations Specialist

Pi-Cardia is a dynamic medical device company pioneering innovative cardiovascular solutions.

We are committed to transforming patient care through cutting-edge clinical technologies and global research.

We are looking for a motivated and detail-oriented Clinical Operations Specialist to join our growing Clinical team. In this role, you will play a central part in planning and executing clinical trials, working closely with global sites, CROs, and cross-functional teams to ensure smooth, compliant, and impactful study operations.

Responsibilities

Clinical Study Leadership & Support

• Assist with operational tasks across all study phases, from start-up through closeout, with a focus on early study planning, site setup, and regulatory submissions.
• Coordinate and maintain effective communication with external CROs, core labs, and other vendors.
• Support the preparation and submission of global clinical study applications (including IRB/EC submissions, regulatory filings, and study notifications).
• Collect and organize documentation from study sites, CROs, and external partners.
• Upload and manage clinical trial documents in the eTMF system or other relevant repositories.
• Maintain and update clinical tracking tools (e.g., site activation status, enrollment projections).
• Process study-related invoices and track payment status.
• Contribute to the writing, editing, and review of clinical documents such as protocols, study plans, ICFs, monitoring plans, site manuals, and other study-related materials.
• Lead or actively contribute to the setup of new studies, including feasibility assessments, site qualification, and contract management.
• Study Monitoring & Oversight
• Monitor the progress of clinical studies, ensuring compliance with protocols, timelines, and regulatory requirements.
• Serve as a study monitor (CRA) for selected sites, including conducting initiation, monitoring, and close-out visits as needed (remote and onsite).
• Willingness to travel abroad for monitoring visits occasionally.

General & Cross-Functional Support

• Participate in the development and maintenance of Clinical Operations SOPs and departmental plans.
• Provide cross-functional support to other departments where clinical, regulatory, or documentation expertise is needed.
• Support audit and inspection readiness activities
• Manage administrative aspects such as contracts, insurance, payments

Requirements

Education & Experience

• Bachelor’s degree (or equivalent) in a life sciences, medical, or healthcare-related field.
• Minimum of 4-5 years of progressive experience in clinical operations, including site monitoring/ study management.
• Experience in setting up new clinical trials, including startup documentation, submissions, and site initiation.
• Experience from a medical device company – an advantage.

Skills & Competencies

• Strong organizational skills with exceptional attention to detail.
• Advanced proficiency in Microsoft Excel, including data analysis, manipulation, and reporting.
• Effective communication and interpersonal skills.
• Fluent in English (written and spoken), with strong command of scientific and clinical terminology.
• Proven ability to work collaboratively across teams and manage multiple priorities in a dynamic environment.
• Flexible, proactive, and willing to participate in both high-level strategic tasks and hands-on operational activities.