CPM / CRA / med. writer (clinical phase)

- Supporting clinical trials
- Based near Vienna for Austria or in Munich for Germany

• Clinical Monitor
• Clinical Study Manager
• Regulatory Affairs

Global support as CRA, CPM, or medical / regulatory writer in clinical phase.
Able to remotely support global projects; services with on-site activity are provided for Austria (based off of Vienna) and Germany (based off of Munich).

- All stages of clinical trials (conception, planning, preparation, conduct, analysis, archiving)
- CA submission to various authorities (AGES, BfArM, PEI, MHRA, US-FDA, FAMHP)
- eCTD submission to US-FDA (DMF, pre-IND, IND)
- Comprehensive monitoring experience (from pre-study to close out)
- IEC/IRB submission and communication
- IMPD/DMF authoring
- Essential study documents authoring and review
- ICH-GCP, ISO14155
- Experience with dedicated software systems (CTMS, docuBridge)
- CRO and vendor qualification and oversight, contract negotiation
- Country and site feasibility, site contract negotiation
- Budget creation and oversight
- Teamwork in international teams, interface between departments and team members
- Strong planning and prioritizing skills

Therapeutic areas:
Angiology, autoimmune diseases, dermatology, endocrinology, gastrointestinal system, hematology, hepatology, oncology, ophthalmology, organ transplantation, orthopedics, vaccines