Medical Monitor - Oncology

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 presentationsQualifications:

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 processesDesirable:

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

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