Senior Clinical Operations Specialist

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

📋 Description

• Execute activities in accordance with relevant Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.

• Provide assistance to Clinical Monitoring staff with site management tasks and act as a Sponsor representative for designated study sites.

• Interact with sites to ensure adherence to protocol requirements, study procedures, and applicable guidelines.

• Develop and maintain project files while managing project-related correspondence.

• Engage in file audits.

• Prepare and update site manuals, reference tools, and other documentation.

• Maintain, refresh, and input clinical tracking information into databases.

• Monitor incoming and outgoing clinical and regulatory documents and updates.

• Oversee shared mailbox operations, process site requests, and appropriately route correspondence.

• Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials.

• Assist in team meetings, participate in meetings, and draft meeting minutes and action items.

• Proactively identify, address, and resolve potential issues; implement corrective measures.

• Stay informed about clinical research and complete necessary training.

• May offer training or mentorship to junior Clinical Operations Specialists.

⛳️ Requirements

• Associate's degree preferred or equivalent experience.

• Relevant experience in clinical research, pharmaceuticals, biotech, or a related field may be accepted in lieu of a degree.

• Solid understanding of medical terminology, clinical data, and ICH/GCP is preferred.

• Capability to effectively prioritize and manage multiple tasks simultaneously.

• Strong attention to detail, accuracy, and organizational capabilities.

• Exceptional communication, presentation, and interpersonal skills.

• Willingness to adopt new technologies.

• Minimal travel of up to 10% may be necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Up to 10% travel may be required.