Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Medical Monitor/Clinical Research Medical Advisor - FSP
Job ID R0000034852Position 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
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs