Medical Monitor/Clinical Research Medical Advisor - FSP
Position Overview
Parexel is seeking an experienced Clinical Research Medical Advisor (CRMA) to provide clinical strategic and tactical leadership as a Country Clinical Development representative. The ideal candidate will drive clinical trial excellence through medical expertise, strategic planning, and cross-functional collaboration.
Job Purpose
ā¢ Serve as the accountable leader for all country clinical/medical aspects associated with Development and prioritized research programs/trials
ā¢ Provide clinical strategic and tactical leadership as the Country Clinical Development representative (may work across several countries)
ā¢ Gather, inform, and act on clinical/medical/scientific insights for clinical trial documentation including concept sheets, protocols, and Informed Consent Forms
ā¢ Drive identification and involvement of qualified investigators with greatest recruitment potential
ā¢ Identify clinical recruitment hurdles and implement solutions to overcome these challenges
ā¢ Ensure adherence to safety standards and clinical data quality through general clinical/medical support
ā¢ Collaborate with cross-functional teams (clinical trial operations, Medical Affairs, Patient Engagement) to support successful trial allocation, fast start-up, timely recruitment, and early identification of potential delays
Key Responsibilities
Strategic Leadership
ā¢ Provide Clinical Development and indication expertise specific to Country/Cluster
ā¢ Partner with clinical trial operations teams to drive high-quality trial execution within planned timelines
ā¢ Validate study designs and make final decisions on clinical/medical trial and program feasibility
ā¢ Develop clinical/medical trial plans considering the broader ecosystem to ensure successful implementation
ā¢ Proactively identify clinical challenges and develop mitigation plans
ā¢ Build disease area expertise, especially for new/rare indications
Clinical Trial Implementation
ā¢ Actively contribute to scientific/clinical/medical aspects of trial start-up phase
ā¢ Decide on site/country-specific scientific/clinical/medical content for Informed Consent Forms
ā¢ Ensure appropriateness of patient-suitable language in documentation
ā¢ Provide robust indication, compound, and protocol training to clinical operations teams and other country functions
ā¢ Leverage innovation in clinical trial planning and determine recruitment strategies based on physician interviews and competitive analysis
Stakeholder Engagement
ā¢ Support and partner with internal stakeholders (Clinical Trial Team, Regulatory Affairs, Medical Information, etc.)
ā¢ Interact with external experts including Regulatory Authorities, Medical Experts, Advisory Boards, and Patient Advocacy Groups
ā¢ Represent Clinical Development at investigator meetings and scientific venues to support recruitment and trial awareness
ā¢ Gather insights from clinical trial investigators, site staff, medical experts, patients, and payers to optimize trial implementation
Quality and Compliance
ā¢ Support planning, implementation, and follow-up of regulatory authority inspections and internal audits
ā¢ Review and resolve country trial-related scientific/clinical/medical issues
ā¢ Ensure adherence to safety standards and clinical data quality
ā¢ Provide clinical/medical expertise for pharmacovigilance activities
ā¢ Review clinical aspects of Serious Adverse Events and support patient safety teams
ā¢ Follow up with investigators for additional information regarding Adverse Events and provide expertise for safety amendments
ā¢ Drive all clinical/medical activities in adherence to Good Clinical Practices (GCP) and ICH guidelines
Innovation and Strategy
ā¢ Support innovative study designs through quality assessments of country datasets
ā¢ Provide scientific/clinical/medical input to overall Product strategy at the Country level
ā¢ Deliver superior customer experience for investigators and site study teams
Requirements
ā¢ MD, PhD or PharmD required
ā¢ At least 3 years of experience managing studies from the scientific/medical/clinical perspective in clinical research and drug development in a pharma or CRO setting
ā¢ Strong understanding of clinical trial protocols and regulatory requirements
ā¢ Excellent communication and stakeholder management skills
ā¢ Ability to work across multiple countries and in cross-functional teams
ā¢ Knowledge of GCP and ICH guidelines
#LI-REMOTE
Apply Now
Apply Now
Parexel is seeking an experienced Clinical Research Medical Advisor (CRMA) to provide clinical strategic and tactical leadership as a Country Clinical Development representative. The ideal candidate will drive clinical trial excellence through medical expertise, strategic planning, and cross-functional collaboration.
Job Purpose
ā¢ Serve as the accountable leader for all country clinical/medical aspects associated with Development and prioritized research programs/trials
ā¢ Provide clinical strategic and tactical leadership as the Country Clinical Development representative (may work across several countries)
ā¢ Gather, inform, and act on clinical/medical/scientific insights for clinical trial documentation including concept sheets, protocols, and Informed Consent Forms
ā¢ Drive identification and involvement of qualified investigators with greatest recruitment potential
ā¢ Identify clinical recruitment hurdles and implement solutions to overcome these challenges
ā¢ Ensure adherence to safety standards and clinical data quality through general clinical/medical support
ā¢ Collaborate with cross-functional teams (clinical trial operations, Medical Affairs, Patient Engagement) to support successful trial allocation, fast start-up, timely recruitment, and early identification of potential delays
Key Responsibilities
Strategic Leadership
ā¢ Provide Clinical Development and indication expertise specific to Country/Cluster
ā¢ Partner with clinical trial operations teams to drive high-quality trial execution within planned timelines
ā¢ Validate study designs and make final decisions on clinical/medical trial and program feasibility
ā¢ Develop clinical/medical trial plans considering the broader ecosystem to ensure successful implementation
ā¢ Proactively identify clinical challenges and develop mitigation plans
ā¢ Build disease area expertise, especially for new/rare indications
Clinical Trial Implementation
ā¢ Actively contribute to scientific/clinical/medical aspects of trial start-up phase
ā¢ Decide on site/country-specific scientific/clinical/medical content for Informed Consent Forms
ā¢ Ensure appropriateness of patient-suitable language in documentation
ā¢ Provide robust indication, compound, and protocol training to clinical operations teams and other country functions
ā¢ Leverage innovation in clinical trial planning and determine recruitment strategies based on physician interviews and competitive analysis
Stakeholder Engagement
ā¢ Support and partner with internal stakeholders (Clinical Trial Team, Regulatory Affairs, Medical Information, etc.)
ā¢ Interact with external experts including Regulatory Authorities, Medical Experts, Advisory Boards, and Patient Advocacy Groups
ā¢ Represent Clinical Development at investigator meetings and scientific venues to support recruitment and trial awareness
ā¢ Gather insights from clinical trial investigators, site staff, medical experts, patients, and payers to optimize trial implementation
Quality and Compliance
ā¢ Support planning, implementation, and follow-up of regulatory authority inspections and internal audits
ā¢ Review and resolve country trial-related scientific/clinical/medical issues
ā¢ Ensure adherence to safety standards and clinical data quality
ā¢ Provide clinical/medical expertise for pharmacovigilance activities
ā¢ Review clinical aspects of Serious Adverse Events and support patient safety teams
ā¢ Follow up with investigators for additional information regarding Adverse Events and provide expertise for safety amendments
ā¢ Drive all clinical/medical activities in adherence to Good Clinical Practices (GCP) and ICH guidelines
Innovation and Strategy
ā¢ Support innovative study designs through quality assessments of country datasets
ā¢ Provide scientific/clinical/medical input to overall Product strategy at the Country level
ā¢ Deliver superior customer experience for investigators and site study teams
Requirements
ā¢ MD, PhD or PharmD required
ā¢ At least 3 years of experience managing studies from the scientific/medical/clinical perspective in clinical research and drug development in a pharma or CRO setting
ā¢ Strong understanding of clinical trial protocols and regulatory requirements
ā¢ Excellent communication and stakeholder management skills
ā¢ Ability to work across multiple countries and in cross-functional teams
ā¢ Knowledge of GCP and ICH guidelines
#LI-REMOTE
Apply Now
Apply Now