To manage the setting up and the monitoring of clinical trials within the scope of the clinical development of our company products in compliance with SOPs, ICH guidelines and local/international regulations:
- Provide clinical expertise, strategic planning, and support for all clinical activities.
- Develop specific expertise/medical knowledge and a comprehensive understanding in the therapeutic fields he/she is involved.
- Write synopsis and protocol of clinical studies he/she is assigned to.
- Ensure that study protocols, informed consents, and other study documents are complete and consistent with FDA, EMEA or National requirements to ensure successful review by Competent Authorities (CA) and Institutional Review Boards (IRB)/Ethics Commitees(EC).
- Prepare and submit clinical trial applications to CA and IRB/EC, provide answers to CA and IRB/EC.
- Perform clinical sites selection. Develop and maintain relationships with investigators.
- Obtain contract signatures with institutions and investigators.
- Participate to project team meetings to provide input on trial designs, and oversee the execution of trials.
- Supervise CRA activity to ensure initiation and monitoring visits are done in a proper manner.
- Ensure patients recruitment is on track and prepare contingency plan in case of slow recruitment.
- If appropriate, coordinate the different Clinical Research Organizations (CROs) in charge of the studies. Develop and follow budget for the concerned countries, processes outsourced.
- Write and/or review clinical study reports summarizing the results of a clinical trial consistent with clinical and regulatory requirements in cooperation with Medical
- Writing Department.
- Support efforts to develop scientific abstracts, presentations, and manuscripts for publication of clinical trial data in cooperation with Medical Writing Department.
- If appropriate, submit/exchange with FDA/EMEA to gain approval or thorough review by FDA/EMEA of clinical study protocols, data analysis, and clinical summaries.
- Perform other related duties as assigned.
- Medical Doctor, Pharm. D. or Ph.D. Scientist
- 5 year-experience in clinical development
- Fluency in English
- Good knowledge of the regulatory environment of clinical trials