Clinical Research Medical Advisor
New Yesterday
LOCATION: UK
ROLE TYPE: Remote Working, #LI-Remote
As Clinical Research Medical Advisor (CRMA), you will be accountable for all country clinical/medical aspects associated with Development and prioritized Research programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative.
This will include gathering, informing, and acting on clinical/medical/scientific insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation.
They will drive the identification and involvement of qualified investigators with greatest recruitment potential, identify clinical recruitment hurdles and drive clinical recruitment activities to overcome these hurdles. Accountable for adherence to safety standards and clinical data quality in the country by providing general clinical/medical support for trial related safety findings.
Working in close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs and Patient Engagement) they will also actively contribute to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans.
This is a remote working position with the successful incumbent having to be based in the UK.
Job Description
MAJOR ACCOUNTABILITIES:
From Strategy to Functional Excellence
The CRMA provides Clinical Development and indication expertise specific to Country/Cluster, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines:
- Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country. (Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up).
- Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
- Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language.
- Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
- Develops clinical/medical trial plans taking the broader ecosystem into account for assigned programs/trials to ensure successful trial implementation, which includes pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans & building disease area expertise, especially for new/rare indications.
- Provides clinical/medical expertise to support pharmacovigilance activities. May be involved in reviewing the clinical/medical aspects of clinical trial Serious Adverse Events (SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information. Follows-up with the Investigator for additional clinical/medical information or clarifications for adverse events (AES) and SAEs and provides clinical/medical expertise for safety amendments, Investigator Notifications (INS), Urgent Safety Measures (USM), etc.
- Gathers, informs, and acts on insights from clinical trial Investigators/site staff, Medical Experts, patients, and payers, with internal Stakeholders at the Country/Cluster level with the goal to optimize clinical trial implementation.
- Accountable for adherence to safety standards, clinical data quality for the Country/Cluster and provides general scientific/clinical/medical support for safety issues:
- Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement.
- As the scientific/clinical/medical expert, supports and partners with internal Stakeholders (e.g., Clinical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, Health Economics and Outcomes Research (HE&OR), clinical trial operations, etc.), and internal decision boards as needed regarding clinical trials.
- Meets Country/Cluster specific clinical trial operations Key Performance Index (KPI) targets, particularly those related to trial feasibility and recruitment.
- Drives investigator site performance by providing high quality support to Investigators/Clinical trial site staff for Development and Biomedical Research studies, leading to a superior customer experience.
- Prepares high quality Country clinical trial documents according to agreed timelines especially for IRB/EC/Regulatory Authorities, and Investigator queries as needed.
Work Experience:
- A Medical Degree (MD) qualification is essential for this role
- Ability to manage a study from the scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
- Agility to move quickly across different therapeutic areas and indications.
- Several years of clinical development experience in the pharmaceutical industry or clinical practice.
- Sound understanding of the overall clinical development process, and ICH/GCP principles.
- Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
Ability to assess the feasibility of implementing the protocol based on Country/Cluster medical practice and sound understanding of the overall Clinical Development Plan. - Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.
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Commitment to Diversity and Inclusion:
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Skills Desired
Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um) #J-18808-Ljbffr
- Location:
- United Kingdom
- Salary:
- £80,000 - £100,000
- Category:
- Bio & Pharmacology & Health