Responsibilities and Requirements:
Study Management:
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.
Stakeholder and Vendor Management:
Chair study SMT meetings or vendor calls to drive effective study team collaboration.
Set clear goals and communicate effectively.
Site Training and Engagement:
Provide site/CRO training and maintain training materials (e.g., onboarding slide decks, patient-facing leaflets, video copy editing).
General:
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.
Necessary Competence (education/qualification):
Educational Background
Bachelor’s degree or master's degree in a relevant discipline (nice to have)
Experience
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
Personal Qualities
A passion for improving research in healthcare
Team player who thrives in a growing company