Beschreibung
Senior Clinical Scientist (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- 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.
- You are responsible for delivering the clinical study protocol and contribute to the development of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
- You plan, manage and monitor 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.
- You perform medical monitoring/ reporting including evaluation of adverse events.
- You Review, evaluate and report 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, you contribute 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.
Main qualifications
- Doctorate (DDS, DVM, PhD, PharmD), MSc or equivalent degree in Biological Sciences required and profound 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
- Good organizational skills, good written and verbal communication skills, able to work as part of a team and independently
- Good independent time management skills
- Ability to plan and track deliverables and timelines
- Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business
- Detail oriented
Main advantages:
- A very renowned company
- Continuous support during the assignment
- Interesting tasks in a multinational environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Marc-Sebastian Heftrich
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