Freelance/Consultant/Freiberufler Clinical Research Associate/CRA

4/2013 – 6/2016

Helps to further the clinical development program by assisting in the design and conduct of clinical
trials.
• Be the Medical Expert for assigned clinical trials and is readily available to advise on trial related
medical questions or problems during the conduct of the trial.
• Contribute to investigator training.
• Contributes in the Integrated Summary of Safety and Efficacy
• Assist in medical review, assessment and interpretation of clinical and safety data to ensure that the
data are correct and presented with the appropriate medical interpretation.
• Works closely with others in the medical monitoring team. Also works closely with the
Pharmacovigilance and Safety representatives providing medical input into safety reports including,
SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and
Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety
Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of
Safety and Efficacy, Clinical Study Reports and preparation of labels.
• Responsible for medical monitor expertise input into the development and implementation of
standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting
and assuring compliance with global and local regulatory requirements.
• Attendance at teleconferences and face-to-face meetings with global regulators and KOLs in the
region. Responsible for implementing alignment across policies/procedures and ensure that data
generated meet monitoring and compliance with FDA, ICH guidelines and GCP.

Drug Discovery

10/2006 – 3/2011

Provides medical oversight for clinical and ancillary research products .
-Provides medical insight during implementation of key trial responsibilities.
-provides clinical leadership and strategic input for protocol consistent plans.
-Manages other associates.
-Works in closed collaboration with KOL and other board members.
-Ensures compliance with clinical research and ethical standards

Drug Discovery