Clinical Site Manager

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

📋 Description

• Design, plan, coordinate, and execute activities related to the initiation of clinical research studies at designated sites.

• Oversee comprehensive study start-up operations, including site identification, selection, and activation.

• Manage submissions to the Ethics Committee (EC), Competent Authority (CA), and/or Institutional Review Board (IRB).

• Ensure that trial documentation, local contracts, and institutional approvals comply with regulatory timelines.

• Serve as the primary contact and clinical trial specialist for start-up activities for personnel at assigned study sites.

• Coordinate necessary certifications.

• Create study documentation, which includes informed consent forms and patient instruction manuals.

• Collaborate with global, local, and virtual teams to provide clinical diagnostic solutions.

• Partner with diverse regions, cultures, and time zones to foster inclusive team environments.

• Ensure that studies are executed, documented, and reported in accordance with protocols, standard operating procedures, and global regulatory standards.

⛳️ Requirements

• A degree in a scientific discipline or a related field (or an equivalent combination of education and experience).

• A proven history in clinical operations or clinical trial coordination.

• Practical experience in conducting diagnostic and medical device trials.

• Experience in managing submissions to the Ethics Committee (EC) and Competent Authority (CA).

• Outstanding verbal and written communication skills in English.

• Ability to cultivate trusted relationships and influence cross-functional partners.

• Proficiency in German is an advantage.

• Strong problem-solving abilities.

• Capability to make sound independent decisions.

• Experience in managing relationships with external vendors.

• Ability to thrive in a fast-paced, matrixed environment.

• Flexibility and adaptability for effective cross-team collaboration.

🏝️ Benefits

• A discretionary annual bonus may be available based on individual and Company performance.

• Benefits detailed at the provided link.