Clinical Research Scientist

For our client, Switzerland's leading medical device company, we are looking for Research Scientist to support the clinical science team. This is a one-year contract with extension possibility based in Baselland, Switzerland.

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 studies with department, company and regulatory standards and procedures. The incumbent will support the Pulmonary Hypertension TA.

Tasks & Responsibilities:

• Delivering the clinical study protocol and contributing to the development of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
• Planing, managing and monitoring 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.
• Performing medical monitoring/ reporting including evaluation of adverse events.
• Reviewing, evaluating and reporting results of clinical studies.
• Managing study-related committees, external medical experts etc.
• Ensuring that all activities are in compliance with department, company and regulatory standards and procedures.
• As requested, contributing 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, participating on cross functional teams, e.g. improvement of processes, etc.

Requirements:

• PhD, PharmD, DVM, MSc (or equivalent) degree in Biological Sciences required.
• 5+ years ' experience in Clinical Development, and hands on experience on conducting clinical trials.
• 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 computer systems and software skills.
• Excellent English, other languages advantageous.

General Information:

• Duration: 12 months with high extension possbility
• Location: Allschwil BL
• Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. Should you have any questions please contact Nastasia Whyte on +41 61 282 22 13 or

Even if this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland. Check out all of Experis' job openings at www.experis.ch.