For our client, an international company in the field of pharmaceutical products and medical devices, we are looking for a
Senior Clinical Scientist 100%
Contract type: external temporary assignment
Location: Allschwil BL
Start of assignment: 18th October 2021
Duration: planned until 15th October 2022 (prolongation: to be discussed)
The focus of this position is to plan, design, scientifically monitor and report clinical studies. You will be responsible for the compliance of the assigned clinical studies with department, company and regulatory standards and procedures. In this role you will support the Pulmonary Hypertension Therapeutic Area.
* 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)
* Plans, manages and monitors daily activities of clinical studies which require scientific input (e.g. contribution to answers to trial-related Health Authorities' questions, answer to Ethic Committees /Institutional Review Boards questions)
* 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)
* As requested, participates on cross functional teams (e.g. improvement of processes)
* PhD, PharmD, DVM, MSc (or equivalent) degree in Biological Sciences required
* At least 5 years of 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.)
* Good leadership skills
* Demonstrated analytical skills
* Excellent computer systems and software skills
* Excellent English, other languages advantageous
Please apply online. We are looking forward to getting to know you.