- Our company is the leading global provider of outsourced early clinical research services.
- Customers include the leading global pharmaceutical companies as well as a number of biotechnology and small to mid sized pharmaceutical companies.
- Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development.
- Our company provides these services through three clinical research units with over 600 beds located in the US and Europe.
- In addition,our company provides clinical research services through partnerships with other clinical research units in North America, Europe and Asia.
- Supporting our clinical work are two world class bio analytical laboratories located in Europe and the US.
- Our company is unique from other leading CROs in that our sole focus is on first-in-man studies to clinical proof-of-concept, as well as clinical pharmacology studies to support product labeling, in contrast to other leading CROs who provide services from discovery to the market.
- Early Clinical Research and studies required to support product labeling
- Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD, medical writing and reporting)
- Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules)
- Drug Development Services (Regulatory affairs and drug development consultancy)
- Global Clinical Development including global multi-site studies conducted outside of company clinics
- Carry out auditing of Line of Service (LOS) (Global Clinical Development (GCD) is a clinical operations department) study procedures, data, records and documentation to assure compliance with study protocols, procedures, and applicable regulatory requirements (laws and industry standards) and guidelines; report audit findings via QA audit reports; and determine acceptability of the responses and verify the corrections/corrective actions.
- Perform system audits and audits of study phases; report audit findings via QA audit reports; determine acceptability of the responses and verify the corrections/corrective actions.
- Review study conduct issues, deviations, investigations, and change control documentation; and assess acceptability of the content and documentation.
- Maintain QA files and QA audit reports.
- Interact with internal clients to discuss QA observations and study related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Perform other functions as assigned by quality management.
- Providing consultancy on Quality Management System(QMS) and Good Practice (GxP) topics
Quality Management System:
- Participate in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
- Detect Quality Issues and need for CAPAs, and assist quality management with the QI/CAPA process.
- Participate in the review and/or writing of SOPs and other controlled documents, as required
- Update/maintenance of company SOP binders and training records
Client/Sponsor Audits and Regulatory Authority Inspections:
- Assist with the preparation for and hosting of client/sponsor audits and/or regulatory inspections.
Facility Based Audits (internal):
- Participate in the preparation and execution of internal Facility based audits.
- Assist in vendor management through conducting QA audits of current and potential vendors via questionnaires and remote auditing.
- Bachelor’s degree in science or similar
- 1 - 5 years quality experience
- 4+ years of pharmaceutical/device clinical research experience
- Working knowledge of applicable Line of Service (LOS) (GCD)/function regulations and guidances (GCP/cGLP/cGMP and 21CFRPart 11, regulations and related guidelines, as well as local regulatory authority regulations as required.
- Excellent oral and written communication skills in English and German; knowledge of other languages advantageous
- Ability to organize and manage multiple priorities
- Good time management skills
- Collaborative team player, open minded, ethical and culturally sensitive
- Adapts well to change, decisive, tenacious and versatile
- Logical, observant, perceptive and good listening skills
- Attention to detail, tactful, and diplomatic
- Computer literate
- Flexible and willing to travel on occasion