ROLE SUMMARY
The clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials.
The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds.
ROLE RESPONSIBILITIES
* Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
* Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP). Perform and document regular review of individual subject safety data, and review cumulative safety data with the safety risk lead. Delegate as appropriate to the study clinician scientist identified in the SSRP.
* Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provide appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context.
* Participate in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
* Review literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
* Communicate safety information to sites across the study and provide responses to questions on safety.
Protocol design and strategy:
* Contribute towards the medical input during protocol development and updates to the clinical development plan.
* Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and have been reviewed by IRB/IECs.
* Provide medical input into country feasibility.
Support study team
* With supervision of medical monitor (director/Sr director) provide clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
* Contribute to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
* Work with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
* Contribute to medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top‑line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
* Provide protocol specific training to study team, investigators, clinical research associate, and others.
* Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
* Interact with DMCs and steering committees as required.
* Monitor investigator compliance with protocol and regulatory requirements.
* Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.
* Support the program team: under supervision (director/Sr director) author clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
* May co‑author abstracts, posters, presentations and publications.
* May contribute budget execution of protocols.
BASIC QUALIFICATIONS
* Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year.
* Possesses the ability to critically evaluate medical/scientific information.
* Excellent written and oral communication.
* Understands the design, development, and execution of clinical programs and studies.
* Capacity to adapt to a fast pace and changing environment.
PREFERRED QUALIFICATIONS
* Medical degree (M.D./D.O. or equivalent).
* Documented work experience/knowledge of statistics.
* Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.
* Experience with clinical trials is preferred.
* No pharmaceutical industry experience required.
WORK LOCATION ASSIGNMENT
Hybrid
APPLICATION DEADLINE
The closing deadline for applications is January 11th.
EEO STATEMENT
All applicants must have the relevant authorisation to live and work in the UK.
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