Clinical research physician
Location
England | United Kingdom
Job description
Clinical Research Physician, CNS
Our client is a Biotech company with an exciting pipeline of drug compounds in development, now have approval for a Clinical Research Physician role within the Clinical Science team, for early-stage and late-stage CNS studies. This hire will be based in Ireland / UK. Travel to sites is required, mainly in the EU region.
In this hands-on role, you will assist in the medical monitoring of clinical trials, establishing plans and seeking unconformity signs and responding to questions raised by the investigators.
Additionally, this hire will ensure medical and scientific quality of the clinical trial protocol, of relevant clinical documents for completeness and accuracy and of the clinical trial report. You will work closely with internal and partners, leading development plans to promote scientific excellence and regulatory compliance.
This hire will contribute to the documentation of the clinical development programs and the overall product development and evaluating the efficacy and safety of drug candidates in human studies.
Responsibilities include:
- Support the project management team in medical issues related to clinical trial.
- Ensure the medical revision of the notifications of SAEs (serious adverse events) before submitting them to the authorities.
- Ensure the discussion of the outline of the trial with other elements of the group and other internal/external stakeholders involved in the trial.
- Ensure the medical review of the IMPD (Investigational Medicinal Product Dossier) and IB (investigators brochure).
- Ensure the review of medical and scientific publications of results of the trial. Review of medical reports of safety information.
- Provide timely responses to medical issues related to the trial, made by internal organs, researchers, authorities and relevant external entities to the trial in question.
- Presentations in investigators meetings, participations in meetings and trainings related do the studies and pipeline.
Requirements include:
- Medical Degree required. Psychiatrist preferred.
- 3+ years of relevant clinical research / clinical development experience, working to ICH/GCP guidelines in the biotech or pharmaceutical industry, or clinical setting is preferred.
- CNS is preferred and other complex therapeutic experience.
- Medical monitoring, and/or safety monitoring experience required, ideally on clinical trials Ph I-III studies.
- Demonstrates medical writing skills of clinical documents, including clinical study protocols, clinical reports, etc.
- Knowledge of compliance and regulatory requirements in clinical trials and drug development.
- Superb communicator of technical and scientific information, multilingual a plus.
- Able to travel within the EU region and EU regional passport as required.
- Ability to effectively present complex data and strategy to large groups.
- Exhibits high motivation and high energy level, self-starter.
For further details, please contact Larry on +353 1 – 2302400 / [email protected]
The RFT Group , BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
Follow us on Twitter, Facebook and LinkedIn
Job tags
Salary
