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Clinical Affairs Manager
Basic Job Purpose:
MobileODT is an award-winning Femtech startup with a breakthrough optical diagnostic device focused on cervical cancer detection and other medical purposes. We are driven by the mission to deliver an affordable, accessible and innovative solution with high adaptation and impact. Our colposcope system is supported by Artificial Intelligence and machine learning algorithms, mobile and cloud-based. We are looking Clinical Affair Manager to oversee all clinical activities in the company and establish a clinical strategy for multiple territories.
MobileODT is looking for a Clinical Affair Manager to lead the next product clinical strategy and be responsible for the clinical aspects of medical device projects at all product life cycle, clinical affairs activities and special projects
MobileODT combines the capabilities of optics with the connectivity of mobile phones. We are looking for a professional that can be at least 50% hands-on, a strategic thinker and leader, able to get things done and dive down to the finer details. MobileODT offers a challenging and meaningful work environment, using technology to save lives.
- Full support to Regulatory, Product and Clinical Strategy, including:
- Support product regulatory submission to FDA, cFDA and EMEA
- Preparation of clinical knowledge scientific documents
- Development and execution of Post-marketing clinical plan
- Planning and execution of clinical trials and different clinical activities (MPT, IST, LME) according to GCP and following company SOPs including:
- Contract negotiation, preparation of trial-related documentation, IRB, study initiation visits, site monitoring and training, data collection, analysis, and reporting, collaborating with physicians towards the publication of study results
- Support Business Units activities from the scientific/medical point of view in strategic thinking, planning and execution including:
- Writing and review of clinical marketing materials and white papers
- Contact person in any communication with leading physicians, KOLs, and consultants
- Literature search and providing clinical publication supporting materials
- Active participation in scientific meetings / lectures / congresses
- Support of R&D process of medical devices, including:
- Clinical application requirements
- Risk management process
- Support in training according to internal and external needs
- Support complaints investigations and vigilance report review
- Initiate KOL activity and support existing KOLs
- Oversee clinical training and physician interaction in the field
- degree in life sciences or equivalent
- Experience of at least 1-2 years in a medical devices company
- Regulatory/Clinical documents writing
- Ability to independently lead clinical research
- High interpersonal skills
- Fluent in English
- Excellent teamwork skills
- Strategic thinking
- Presentations skills
- Leadership skills
- Willing to travel
MobileODT is looking for a junior QA person to join our team. This job will include collaborating with product, developers, and other testers to understand product and feature requirements. The candidate will be responsible for creating and running component and end-to-end test plans across our entire software system. (Backend, mobile app and web portal), as well as assisting with regression testing.
The candidate will be required from time to time to produce reports based on SQL/Mongo. They will also be required to run regulatory testing on our software prior to software release and generate reports and logs
This position will provide room for growth into automation down the line.
- Knowledge and understanding of QA methodologies
- Experience with Agile
- Get it done attitude
- Communicative nature
- High-level English
- strong and proven ability in test creation and documentation
- ability to demonstrate and think of testing on a system scale level
- Understanding of web and mobile testing and testing tools
- Experience writing detailed queries with SQL, Mongo DB
- Experience with API Testing
- Prior knowledge with appium/selenium, Java-based.
- Familiarity with medical devices.
- Team player
- Self Learner
- Ability to identify the need for additional requirements
SQL Student (part-time)
MobileODT is looking for a part-time SQL programmer to assist in migrating data from a legacy system. This job will include handling sensative medical information and moving it between two database formats. The job will take one day a week and is open for students with no prior experience.
- Good SQL skills, including knowledge of joins
- Basic understanding of Excel and Google Sheets
- Attention to details
- A responsible person that can maintain the confidentiality of sensitive medical information
- Understanding of MongoDB queries
- Prior experience with MySQL queries
- Basic comprehension of Python code