Senior Clinical Study Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Lead cross-functional trial teams consisting of Site Management, Monitoring, Data Management, Biostatistics, Safety, and Clinical Logistics.

• Spearhead country and site feasibility across Europe, selecting locations based on the requirements of clinical trial designs.

• Author, review, and approve clinical study protocols and informed consent forms to ensure scientific integrity, compliance with regulations, and adherence to ethical standards.

• Ensure compliance with protocols, facilitate timely data entry, resolve queries, and manage deviations.

• Coordinate with ethics committees and relevant authorities as necessary.

• Maintain documentation that is inspection-ready, promote continuous improvement, and capture lessons learned.

• Act as the primary contact for both internal and external stakeholders.

• Prepare updates, risk assessments, and decision briefs for senior leadership.

• Develop timeline plans and proactively manage the pathway to achieve trial milestones (e.g., First Patient In).

• Provide strong oversight of vendors (e.g., CROs), addressing and resolving issues as required.

• Lead and drive strategic initiatives, coordinating efforts across functional teams to ensure timely and high-quality execution.

⛳️ Requirements

• Demonstrated experience in leading clinical trials across all phases, including startup, execution, and closeout.

• Background in medical devices and/or clinical trials in diabetes.

• Proficient in using clinical management systems and electronic data capture systems.

• Previous participation in inspections or audits.

• Familiarity with post-market clinical follow-up, registries, real-world evidence, or adaptive designs.

• Detail-oriented with strategic thinking, problem-solving skills, and the ability to drive decision-making.

• Exceptional verbal and written communication skills.

🏝️ Benefits

• A comprehensive and extensive benefits program.

• Opportunities for growth on a global scale.

• Access to career development through in-house learning programs and/or eligible tuition reimbursement.

• An exciting and innovative organization that is industry-leading and dedicated to our employees, customers, and the communities we serve.