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

• 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

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.