Our client are a fast growing research and consultiong company assisting with new discoveries in cancer drug development.
The Oncology Medical Monitor will join a team of oncologists, each independently overseeing assigned studies.
The role can be based remotely in the UK or selected European locations (e.g. Scandinavia, Spain, Ireland, Italy, France, Switzerland Germany etc.)
Role:
You will assume Medical and Safety oversight for clinical trials conducted and provides medical input when needed.
Work collaboratively with cross-departmental medical monitoring activities (e.g. clinical operations; project management; pharmacovigilance; business development; biometrics; regulatory and technical writing) to drive best practice across the organisation.
Accountabilities:
- Provide scientific and medical guidance to Oncology project teams to ensure scientific and client/project goals are met
- Act as Medical Monitor for multiple clinical studies- responsible for all clinically related protocol questions, eligibility questions, adverse event evaluation and safety concerns, dosing modification, patient study decisions, medical review of study data, leading data and/or safety monitoring committee teleconferences when applicable
- The Medical Monitor Oncology will act as pharmacovigilance physician for assigned clinical trials to provide safety assessments for Serious Adverse Event reports and develop Safety Reports as needed in coordination with the Safety Desk
- Interact with biostatistics, pharmacokinetics, pharmacovigilance and regulatory affairs professionals
- Contribute to the development and oversight of key internal and external documents related to clinical trial conduct including: clinical trial protocols, informed consents, case report forms, project plans, clinical study reports and meeting abstracts or publications
- Train Oncology staff regarding clinical aspects of drug development, general medical knowledge relevant to the conduct and monitoring of oncology trials, and the mechanism of action and known risks of drugs under study
- The Medical Monitor will provide scientific, clinical and oncology expertise during new project bid proposal development and defense presentations
Qualifications:
- Board Certified MD in Oncology/Haematology
- Ideally PhD in a relevant research field
- Clinical experience in Oncology & active participation in clinical trials
- Comprehensive understanding of clinical research processes
Desirable:
- Participation as an investigator in cancer clinical trials
- Post-graduate Qualification in Clinical Pharmacology / Pharmaceutical Medicine
- Pharmacovigilance experience
- Good Clinical Practice (GCP) and familiarity with regulatory requirements
- Working in either a CRO, biotech or pharmaceutical company
- GMC Registered with a License to Practice
To find out more about Real, please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales