Clinical Trials Quality Compliance Specialist mwd
Clinical Trials Quality Compliance Specialist mwd
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Your role
You are working in the Clinical Research & Development department which conducts firstinman clinical trials and Phase III proofofconcept studies for our new assets worldwide.
- You ensure GCP compliance for the clinical trials in collaboration with Quality Assurance to support our departments objectives in meeting and GCPcompliance by providing structure identifying and supporting the resolution of issues on trial and process level through
- With respect to our activities you closely collaborate with the Quality Assurance department and crossfunctional Clinical Research & Development teams to develop QA/QC measures
- In addition you also plan and conduct activities related to compliance and inspection readiness including quality checks of TMFs and processes. You review and improve processes for efficiency effectiveness and compliance with regulations guidelines and quality policies and support site/CRO assessments.
- You will also coordinate and support functional/clinical trial teams in audit/inspection activities to ensure a consistent approach/action across clinical trials and programs. To improve functional processes and foster a culture of continuous improvement you identify analyze track and resolve findings regulatory and process gaps/ nonconformances.
- By developing and implementing a lessonslearned culture you help to improve the quality of processes and documentation (in compliance with regulations guidelines quality policies) and minimize associated trial risks.
Qualifications :
- You hold a Bachelors Degree or equivalent qualification in Life Sciences / Healthcare; Masters degree preferred.
- You have several years of clinical/industry/health authority experience including a strong focus on quality and compliance. You acquired a thorough knowledge of Good Clinical Practice regulatory guidelines (FDA/EMA/ICH) and the clinical development process. In addition you are experienced in audits or inspections (e.g. FDA EMA).
- You have strong analytical skills with attention to detail and are a problem solver. You are a highly motivated openminded team player with a proven ability to take initiative prioritize and meet project deadlines in a dynamic environment.
- You are naturally communicative and have effective communication (verbal and written) and organizational skills both in English and German.
- A sound knowledge of Microsoft and electronic clinical trial applications e.g. eCRF eTMF or CTMS is expected.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
