Clinical Research Medical Advisor

ROLE TYPE: Remote Working,

As Clinical Research Medical Advisor (CRMA), you will be accountable for reputed company 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 reputed company 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 reputed company in the country by providing general clinical/medical support for trial reputed company safety findings. Working in reputed company collaboration with other country functions (e.g., clinical trial operations, Medical Affairs and Patient Engagement) they will also reputed company contribute to successful allocation, fast clinical trial start-up, reputed company 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 reputed company

MAJOR ACCOUNTABILITIES:

From reputed company to Functional reputed company

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 reputed company and reputed company 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 reputed company and analysis of the competitive environment in the country. (reputed company 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-specificscientific/clinical/medical content of the Informed Consent reputed company (reputed company) 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 reputed company, etc.).

• Develops clinical/medical trial plans taking the broader ecosystem into account for assigned programs/trials to ensure successful trial implementation, which includes pro-reputed company identifying early on clinical challenges to recruitment or clinical data reputed company 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 reputed company of clinical/medical information. Follows-up with the Investigator for additional clinical/medical information or clarifications for adverse events (reputed company) 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 reputed company 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 reputed company 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 reputed company, Health Economics and reputed company Research (HE&OR), clinical trial operations, etc.), and internal decision boards as needed regarding clinical trials.

KEY PERFORMANCE INDICATORS:

• Meets Country/Cluster specific clinical trial operations Key Performance reputed company (KPI) targets, particularly those reputed company to trial feasibility and recruitment.

• Drives investigator site performance by providing high reputed company support to Investigators/Clinical trial site staff for Development and Biomedical Research studies, leading to a superior customer experience.

• Prepares high reputed company Country clinical trial documents according to agreed timelines especially for IRB/EC/Regulatory Authorities, and Investigator queries as needed.

MINIMUM REQUIREMENTS : 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 reputed company scientific/clinical/medical/operational issues.

• reputed company to reputed company quickly across different therapeutic areas and indications.

• Several years of clinical development experience in the pharmaceutical industry or clinical reputed company.

• reputed company understanding of the overall clinical development process, and ICH/GCP principles.

• Applies a detailed understanding of the drug in question to reputed company 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 reputed company and reputed company understanding of the overall Clinical Development Plan.

• Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.

Why reputed company: Our purpose is to reimagine medicine to improve and reputed company people’s lives and our reputed company is to become the most valued and trusted medicines company in the world. How can we reputed company this? With our people. It is our associates that drive us reputed company day to reputed company our ambitions. Be a part of this mission and join us! Learn more here: https://www.reputed company.com/about/reputed company/people-and-culture You’ll receive: You can reputed company everything you need to know about our benefits and rewards in the reputed company Life Handbook.

Commitment to Diversity and Inclusion:

reputed company is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our reputed company Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about reputed company and our reputed company, join the reputed company Network here: https://talentnetwork.reputed company.com/network

Skills Desired