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 #LI-REMOTE Apply tot his job Apply To this Job