Clinical Operations Manager

Your mission

Indivi is a medical technology company enabling precision medicine to become a reality in neuroscience research and development.

The company is going through significant growth and looking for new team members to join and contribute to making the company vision a reality.

Your profile

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

Flexible Opportunity

We value flexibility in our workforce, so both part-time and full-time arrangements are considered!

About us

We are looking for highly motivated and experienced people with our like-minded focus on improving the lives of people with neurological disease.

Indivi is an equal opportunities employer and encourages applications from candidates of all backgrounds, particularly those from underrepresented groups.

Reasonable adjustments will be made wherever possible.

https : / / indivi.io