Clinical Operations Manager

3 days ago

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Indivi

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e-health • clinical trials • neurology • neurodegeneration • digital health technology

51 - 200

Description

• Develop and execute clinical operations and study management strategies. • Align study configurations with product leads and owners. • Ensure compliance with SaMD standards, GCP, QMS, and RAQA regulatory requirements as well as standards agreed with clients. • Provide input and management of relevant study documentation e.g. protocol writing for IRB submissions, adverse events reporting etc • Create and maintain operational and quality oversight documents e.g. inventory levels, system availability etc. • Generate weekly study reports and ensure resolution of non-conformances and CAPAs. • Identify and resolve or escalate study management issues proactively. • Manage and prioritise clinical study site support tickets through the CRM system (e.g., Zendesk) • Ensure timely and effective resolution of tickets, providing high-quality customer service. • Collaborate with cross-functional teams and vendors (e.g., product, engineering) to address and resolve complex issues. • Chair study SMT meetings or vendor calls to drive effective study team collaboration. • Set clear goals and communicate effectively. • Provide site/CRO training and maintain training materials (e.g., onboarding slide decks, patient-facing leaflets, video copy editing). • Contribute to budget forecasting and tracking at the study level. • Provide input on product development and suggest improvements. • Perform additional ad hoc tasks to support Indivi programme management.

Requirements

• Bachelor’s degree or master's degree in a relevant discipline (nice to have) • At least 2-3 years of experience in clinical trial operations involving digital solutions within the pharmaceutical industry • Experience working in an environment focused on software development within medtech • GCP certification