Medical Monitor/Clinical Research Medical Advisor - FSP

Job Description:

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