Job Opportunities in Netherlands
September 24, 2024
XS Innovations
Leiden
FULL TIME
Junior Medical Officer
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:
Werkschema:
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.
Werkschema:
- ma-vr
- clinical research: 1 jaar (Gewenst)
We regret to inform you that this job opportunity is no longer available
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