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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical direction for clinical trials, providing strategic and tactical contributions to drug development and project execution. Possesses extensive clinical research experience and the ability to lead cross-functional teams while ensuring compliance with regulatory standards.
Highest-signal resume keywords
MD DegreeClinical Research LeadershipDrug Development ExpertiseMedical Monitoring ExperienceRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trials ManagementMedical Data ReviewProtocol DevelopmentSafety MonitoringFeasibility AssessmentProject Risk AssessmentTraining Module DevelopmentCME ParticipationData Safety Monitoring Board ActivitiesClinical Research Experience
Soft Skills
LeadershipCollaborationCommunicationFlexibilityInterpersonal Skills
Tools & Technologies
Clinical Trial SoftwareData Analysis ToolsProject Management ToolsMedical Coding SoftwareRegulatory Submission Tools
Certifications & Qualifications
MD/DO Professional DegreeBoard CertificationRelevant Subspecialty Fellowship
Industry Keywords
Pharmaceutical IndustryCROClinical DevelopmentInvestigational SitesEthics CommitteesHealthcare ProfessionalsQuality ImprovementBusiness DevelopmentClient ProposalsTherapeutic Area Expertise
About the role
Key responsibilities & impact- Provide medical direction for the conduct of clinical trials
- Support development activities for proposed and ongoing projects in the relevant area of expertise
- Perform medical monitoring for assigned clinical studies
- Drive projects from an overall company perspective beyond the medical perspective
- Provide strategic and tactical subject matter expertise for client proposals, bid defenses, business development, quality/process improvement and audit activities
- Contribute to company policies involving medical, safety and therapeutics
- Provide cross-functional scientific and technical contributions and interact with client medical teams, project teams, key opinion leaders and investigators/sites
- Partner with GCO to develop new and enhance existing client relationships
- Participate in proposal teams and provide medical/scientific capabilities to clients and internal teams
- Perform site/investigator feasibility and build investigator relationships to support recruiting and trial conduct
- Interact with study teams, functional groups, investigational sites, regulatory authorities, ethics committees, safety monitoring boards and healthcare professionals
- Support and participate in departmental recruitment
- Provide leadership and present medical/scientific capabilities to clients
- Manage, supervise and delegate activities to up to 5–10 direct and indirect reports as applicable
- Serve as Global, Regional or Program Lead Project Physician across multiple indications as assigned
- Provide drug development expertise and contribute to medical strategy and study/program execution
- Review and revise protocols, case report forms, training materials, project tools, analysis plans, clinical trial reports, data tables, listings, figures and new drug applications
- Prepare materials for and participate in investigator meetings and assist at site initiation visits
- Provide medical and scientific expertise to project teams
- Conduct medical and safety monitoring and participate in project risk assessment
- Perform medical data review and oversee central medical data review where applicable
- Review and act upon safety alerts as required
- Support medical review of coding
- Assist with data safety monitoring board activities
- Review medical monitoring scope of work, hours and budgets
- Oversee medical monitoring activities, timelines and quality of deliverables, assigning physician resources as required
- Maintain subject matter expertise through CME, clinical work and relevant conferences/meetings
- Develop training modules and provide disease-area and protocol-specific training
- Participate in process improvement activities
- Represent the company at conferences and scientific meetings
- Lead therapeutic-area initiatives involving physicians across the therapeutic area
- Perform other duties as assigned
Requirements
What you’ll need- MD degree required
- MD/DO professional degree/designation/certification/license legally required
- Relevant subspecialty fellowship training and history of board certification, as appropriate
- Recognized as a clinical research leader with substantial knowledge of drug development
- Extensive clinical research experience within the pharmaceutical/industry in a specific therapeutic area, which can be a substitute for the board certification specialization, as appropriate
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- A minimum of 3–10 years of experience with substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area
- Generally, 2–5 years of clinical trials medical monitoring experience or other relevant clinical development/trial experience at a CRO, pharmaceutical company, regulatory agency or clinical practice
- Legally authorized to work in the United States without current or future employer-sponsored work authorization
- Ability to provide out-of-hours and 24/7 emergency medical cover as scheduled
- Flexibility to participate in meetings across various time zones
- Occasional domestic and international travel may be required
- Frequently stationary for 6 to 8 hours per day
- Repetitive hand movement of both hands and ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching and stooping, with frequent bending and twisting of the upper body and neck
- Ability to access and use varied computer software
- Light to moderate lifting and carrying of objects, including luggage and laptop computers, up to 15 to 20 pounds
- Regular and consistent attendance
- Varied hours may be required
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability (STD) insurance
- Long-term disability (LTD) insurance
- 401(k)
- Paid Time Off (PTO) or Flexible Time Off (FTO)
- Company bonus programs where applicable
- Comprehensive benefits for regular full-time or part-time employees working 20 or more hours per week
