For our client, a leading international pharmaceutical company with a site in Basel, we are looking or a motivated personality in the function of
Senior Clinical Scientist
The focus of this position is to plan, design, scientifically monitor and report clinical studies. The incumbent is responsible for the compliance of the assigned clinical study(ies) with department, company and regulatory standards and procedures.
- Is responsible for delivering the clinical study protocol and contributes to the development of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
- Plans, manages and monitors daily activities of clinical studies which require scientific input, e.g. contribution to answers to trial-related Health Authorities' (HA) questions, answer to Ethic Committees /Institutional Review Boards questions, etc.
- Performs medical monitoring/ reporting including evaluation of adverse events.
- Reviews, evaluates and reports results of clinical studies.
- Manages study-related committees, external medical experts etc.
- Ensures that all activities are in compliance with department, company and regulatory standards and procedures.
- As requested, contributes to the development and execution of clinical research programs for assigned company products, e.g. Clinical Development Plans, Clinical Overviews, HAs' Briefing Books, HAs' Annual Reports, Pediatric Investigational Plans, etc.
- As requested, participates on cross functional teams, e.g. improvement of processes, etc.
- Doctorate (DDS, DVM, PhD, PharmD), MSc or equivalent degree in Biological Sciences required and ?5 years experience in Clinical Development, and hands on experience on conducting clinical trials.
- Strong experience in clinical delvelopment and real world evidence
- Excellent communication skills and the ability to prioritise as you will be working simultaniously on more than one study
- Knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines based on previous deliverables
- Prior experience of working in a matrix organization including interactions with all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external service providers, etc.).
- Excellent English, other languages advantageous.
Place of work: Basel
Duration: 1 year, extension possible
Please apply online. For further information about the position, please contact: Mrs Diana Steinhauer (+41 61 270 80 16).