CLINICAL RESEARCH PHYSICIAN (closed)
Our client is an expanding pharmaceutical company who are genuinely looking for a Clinical Research Physician and who will appoint without equivocation should the right candidate present.
The Clinical Research Physician is responsible for providing clinical input into the design, conduct and reporting of company clinical studies, and provides medical support for global drug safety and risk management activities.
To achieve success it is critical that the Clinical Research Physician:
Brings all medical knowledge and experience to bear to ensure safe treatment of subjects in our clinical studies, and to review relevant safety information for our marketed products to ensure that we are working with the best available view on product risk.
Works in a collaborative manner within the clinical development team, recognising that clinical and medical input is one part of the team approach to success.
Brings personal medical opinion but is also able to represent and work with alternative views, and support team consensus.
Can switch between strategic thinking, involving a broad global perspective, and working at a detailed level, where accuracy and attention to detail are required.
Can prioritise, recognising the need to support team and personal goals in order to meet deadlines.
a) Provide Input into Clinical Development Programmes:
Work within the product development teams to discuss and agree clinical programmes and study design to meet safety and efficacy endpoints.
Bring an overview of the product attributes, competitor landscape and regulatory needs and constraints, to the discussion.
Work with the study team to develop study synopsis and completed protocols.
b) Be part of the study team:
Work with the study team in defining the responsibilities and activities of the CRO, and be part of the reviewing and selecting process for contractors.
Work to aid the CRO and study team in understanding the disease, treatment pathways, complications and delivery of treatment. Ensure that the medical aspects of the protocol are trained in a thorough and safe way.
Liaise with potential investigators and study sites, along with the study manager, to evaluate suitability for clinical studies.
Engage with the CRO and study staff to assist with patient recruitment tactics and work with the team to keep recruitment on-track.
Be the medical monitor on company studies when required; provide back-up to other medical monitors when required.
Monitor and review study data on an ongoing basis, if needed.
Liaise with medical affairs and commercial colleagues to support investigator sponsored studies.
c) Data review, interpretation and presentation:
Review study data, as part of quality control, and as part of clinical evaluation.
Provide medical opinion and insight on data; contribute to medical writing of study reports and aggregate reviews and reports.
Take part in presenting data and conclusions to internal and external stakeholders.
Review essential clinical documents such as relevant literature, protocols, investigator brochures, protocol amendments, study reports, references and aggregate regulatory documents.
d) Provide Medical Support to Global Drug Safety and Risk Management:
Provide medical interpretation of safety data; suggest lines of follow up.
Be the primary contact for medical review of safety reports in PV and safety review of assessment reports for risk management, when required.
Be part of the safety review team for aggregate safety data, as part of periodic safety review. Review and comment on periodic safety reports, risk evaluation reports and risk management reports.
Contribute to development safety planning for studies, including post marketing authorisation studies.
Contribute to the design of Risk Management plans, when required.
Provide initial review of information relating to manufacturing related risk assessments.