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