Junior Medical Officer

3 dagen geleden

Leiden, Nederland XS Innovations Voltijd

As a Junior Medical Officer, you will support the CMO and CSO in the planning, execution, and monitoring of (pre)clinical trials. You will play a key role in transforming the clinical team’s ideas into actionable plans and ensuring they meet Good Clinical Practice (GCP) guidelines and regulatory requirements. This is an exciting opportunity for a detail-oriented and ambitious professional to gain hands-on experience in clinical development and trial management.

**Responsibilities**:

- Protocol Support: Assist the CMO and CSO in drafting, refining, and implementing clinical trial protocols.
- Study Documentation: Help prepare and review essential trial documents, including informed consent forms, case report forms, and data collection tools, ensuring compliance with GCP and other relevant standards.
- Site Coordination: Act as a liaison between the company and clinical trial sites, ensuring that sites follow the study protocol and regulatory guidelines.
- Data Monitoring: Support the collection and review of trial data, ensuring accuracy and completeness according to protocol standards.
- Regulatory Compliance: Assist with the preparation of documentation for Ethics Committees/Institutional Review Boards (IRBs) and regulatory submissions (e.g., FDA, EMA), ensuring timely and accurate submissions.
- Training & Support: Provide guidance and training to trial site personnel on protocol adherence, GCP, and other clinical trial processes.
- Quality Assurance: Help monitor trial activities for compliance with the protocol, identifying deviations, and assisting in implementing corrective actions.
- Logistical Support: Assist in managing trial logistics, such as the shipment of investigational products, documentation management, and coordinating communication between team members.

**Qualifications**:

- Bachelor's degree in Life Sciences, Medicine, or a related field.
- Previous experience (1-2 years) in a clinical research setting is preferred but not mandatory. Exposure to clinical trials, GCP, or regulatory processes is a plus.
- Strong organizational and communication skills.
- Attention to detail and ability to manage multiple tasks simultaneously.
- Ability to interpret scientific and medical ideas and translate them into actionable trial processes.
- Familiarity with medical device regulations and standards, quality management systems (QMS) and document control processes.
- Experience writing and delivering reports and technical summaries for clinical submissions and regulatory agencies.
- Excellent problem-solving skills and attention to detail.
- Effective communication and teamwork abilities.
- Ability to work in a fast-paced startup environment and manage multiple projects simultaneously.
- Fluency in English; additional European languages are a plus.

**What We Offer**:

- **Competitive Compensation**: Enjoy a competitive salary and equity options that reward hard work and dedication.
- **Work-Life Balance**: Benefit from flexible working hours and remote work options to fit your lifestyle.
- **Innovative Projects**: Engage in groundbreaking projects that have a tangible impact on patient lives.
- **Dynamic Environment**: Thrive in a high-energy, fast-paced startup environment where every day brings new challenges and opportunities.
- **Collaborative Culture**: Be part of a supportive and inclusive team that values collaboration and diverse perspectives.
- **Career Advancement**: Access numerous professional growth and development opportunities to enhance your skills and career trajectory.
- **Cutting-Edge Technology**: Work with the latest technology and resources to push the boundaries of medical innovation.
- **Fun and Exciting Atmosphere**: Experience the excitement of working in a pioneering medtech startup where your contributions make a real difference.

Soort dienstverband: Fulltime

Werkschema:

- ma-vr

Ervaring:

- clinical research: 1 jaar (Gewenst)

Werklocatie: Hybride werken in 2312 NV Leiden

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