- Supports design of clinical study process and set-up and liaise with cross-functional areas.
- Coordinate multicentric clinical studies and escalate issues
- Adhere to IC HhH GCP guidelines and comply with company SOPs.
- Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. Update study progression
- Maintains Clincial Trial Documentation.(Informed consent forms, Investigator records and site specific SOPs,….)
- Create study specific documentation (protocols, IFUs,..).
- Effectively manage clinical study sites.
- Interfaces with Clinical study team at GBO Austria.
- Prepares intermediate and final reports.
- Supports issuance of clinical, complaint investigations, issuance of white papers and regulatory submissions.
- Clinical Study supply ordering and shipping.
- Ensure data integrity by appropriate participation in monitoring processes
- Implement appropriate systems, processes and standards.
- Selects clinical research sites.
- Support the selection of CROsCommunicates with external parties in regards to clinical research.
- Communicates with Design Center and Clinical Research members of affiliated companies.
- Sponsor representative in clinical study oversight
- Works with regulatory authorities like CLIA, CAP, JCAHO, and FDA on clinical inquiries.
- Bachelor's degree or higher
- 3 years of Clincial laboratory experience or Medical Techonolgy Experience
- Clinical monitoring experience
- Experience in working with regulatory agencies
- Must be able to travel locally and internationally
- Great Motivator. Helps and tries to find solutions for problems. Goes extra mile to help others complete tasks.
- Good organizational and project management skills.
- Accurate, thorough and detailed oriented.
- Must be able to work independently.
- Must have excellent communication and writing skills in English.
- Ability to build strong relationships with partners of different fields of science
- Must pass pre-employment examination, qualification test
- Prefered are candiates with a clinical, medical background like registered Nurse or Medical Technologist.
- GLP / cGCP experience preferred.
- Prefered are canditates with relevant clinical or medical certifications
- Must be able to sit, stand, walk for longer periods of time
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.