Our client, a pharmaceutical company is looking for a
Senior Clinical Scientist
Start date : asap
Contract : 12 months with the possibility of extension
Work location : Allschwill
Office / Home Office : remotely, but the worker can be requested to come from time to time onsite after COVID
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.
Principal Responsibilities :
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.
Principal Relationships :
Cross-functional Trial Team : GCDO Trial Leader, Clinical Scientists (i.e. Study Responsible Scientist), Clinical Trial / Project Physicians (i.
e. Study Responsible Physician)
Contacts Inside the Company : Clinical Pharmacology, Global Clinical Development Operations, Health Economics & Pricing, Global Medical Safety, R&D Project Management Organization, Quality Management, Quantitative Sciences, Regulatory, Trial Supply Management, other departments as needed.
Contacts Outside the Company : Vendors and CRO contacts, academic thought leaders, FDA, European and other health authorities as appropriate.
Supervision : This position reports to Scientific Leader or Principal Clinical Scientist as assigned.
Education & Experience :
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.
Must have a strong experience in clinical development and real world evidence
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 English, other languages advantageous.
Excellent communication skills
Ability to prioritise as he will be working simultaneously on more than one study.
Candidates based in Switzerland or those with a valid Swiss work permit are preferred.