Clinical Operations Specialist

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for a Clinical Operations Specialist to join our team. The Clinical Operations Specialist supports the planning and execution of clinical studies from start-up through closeout, ensuring compliance with protocols, timelines, and regulatory requirements. The role involves coordinating study sites, CROs, vendors, and internal teams, managing essential documentation, and supporting monitoring, process improvement, and audit readiness.

Responsibilities:

Clinical Study 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.
• Manage administrative aspects such as contracts, insurance, payments
• 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).
• Participate in the development and maintenance of Clinical Operations SOPs and departmental plans.
• Process study-related invoices and track payment status.
• Serve as a study monitor (CRA) for selected sites in the IL and possible EU sites.
• Willingness to travel abroad (mostly EU)

Requirements:

Education & Experience

• Bachelor’s degree (or equivalent) in a life sciences, medical, or healthcare-related field.
• CRA and GCP certifications.
• Minimum of 3-4 years of experience in clinical operations, preferably including site monitoring.
• 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.