Clinical Trials Scientist
- Experience Level
I am exclusively partnered with an innovative pharmaceutical company working within a variety of therapeutic areas. The company has a particular focus on underrepresented diseases, addressing areas of high medical need where current treatment and patient satisfaction is low. Aiming to identify and develop innovative products that meet this area of medical need through concentrated research.
The client combines both the drug discovery and the clinical research aspect of the drug development lifecycle to advance innovative drugs on a global level. If you are a scientist with a strong background in clinical trials and research, please read further:
Working with the Science director, you will work closely within cross-functional teams including the study team, project team and internal and external consultant within the whole product lifecycle. You will establish and ensure that the study protocol is contestant with the development plan and maintain quality of data and perform appropriate analysis and reporting of the relevant study data.
- Developing, maintaining and implementing the protocol and study documents relating to the clinical science aspects of the trial. Including but not limited to; study protocol, study reports, data reviews and study development plans.
- Responsible for the quality assurance of the clinical aspects of the trials, including but limited to; study protocol, clinical study reports and clinical data review.
- Responsible for the data review of the trial, including protocol deviation, safety data, efficacy data, data trends and adherence to protocol to ensure objectives are met.
- Managing internal and external functions to report concurrent reviews and results to ensure project plans are met.
- Working with cross-functional teams for production and analysis of pharmacokinetic data and any other specific requirements related to the clinical science aspects of the trial.
- Working in line with GCP and GMP regulations and ensuring training is up to date at all times.
- Contributing to the development and implementation of company SOP’s and policies.
- BSc in life sciences or nursing degree, or equivalent combination of education and experience. Higher degree (PhD) is highly desirable.
- Significant experience demonstrated in the clinical and scientific aspects within the pharmaceutical, biotech or CRO environment.
- Proven experience with regulatory, including ICH and GCP guidelines
- Experience working in a multifunctional team environment working towards times deadline and resource pressures.
- Must be able to work within all levels of the organization internally as well as external clients and partners
- Meticulous and methodical and able to review large sets of data and procedures in detail.
- Excellent communication (both written and spoken), with strong presentation, organization and time management skills.
- Proficient computer skills within all Microsoft suites, email and internet
Interested? Get in touch…..
Vincenzo Dessena MSc BSc