Clinical Operations Manager

vor 3 Monaten

Basel, Schweiz Indivi Vollzeit

**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

**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.

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