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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including protocol development, medical oversight, and compliance with ICH-GCP regulations. Proficient in data management, risk assessment, and effective communication with stakeholders in an international clinical environment.
Highest-signal resume keywords
Oncology ExperienceClinical Trial ManagementICH-GCP ComplianceMedical Training DeliveryData Management Documentation
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Protocol DevelopmentData Review PlansMedical Input on Protocol DeviationsRisk-Based Quality ManagementClinical Quality MonitoringData Visualization SystemsMedical AssessmentsClinical DevelopmentMedical DocumentationStatistical Analysis Plans
Soft Skills
Excellent Interpersonal SkillsActive Listening SkillsInfluencing SkillsStrong Analytical SkillsPresentation Skills
Tools & Technologies
WindowsMS OfficeECRF DesignDigital Technologies
Certifications & Qualifications
Physician MD
Industry Keywords
Pharma IndustryCROGlobal PharmacovigilanceInternal MedicineGeneral Practice
About the role
Key responsibilities & impact- Provide medical responsibility for clinical trials throughout preparation, conduct, and reporting
- Develop and review Clinical Trial Protocols and protocol updates
- Contribute medical expertise to trial risk-based quality management and quality monitoring plans
- Provide medical input on important protocol deviations and trial documentation
- Contribute to data management documentation, eCRF design, data review plans, laboratory specifications, and data transfer agreements
- Provide medical content for patient information, informed consent, monitoring manuals, communication and training plans, and statistical analysis plans
- Contribute to patient narratives and Clinical Trial Report planning and review
- Respond to regulators and Ethics Committees/IRBs
- Provide medical input to study and site feasibility, recruitment, and retention plans
- Deliver medical training to country feasibility teams, trial investigators, or sponsor staff
- Conduct ongoing medical review and document findings and resolutions
- Execute clinical quality monitoring, risk mitigation, and escalation of clinical quality issues
- Identify inconsistencies in medical data and practical protocol execution difficulties
- Respond to medical queries from investigators, CROs, and sponsor representatives
- Build expert networks and contribute to site engagement
- Support Endpoint Adjudication, Data Monitoring Committees, Data Safety Monitoring Boards, and Steering Committees
- Review Trial Newsletters and contribute to scientific publications
- Manage medical activities for one or more clinical trials
- Lead cross-functional planning, execution, and analysis of clinical programs
- Ensure medical assessments, decisions, and medical quality for trials, assets, and client processes
- Complete required training, timesheets, expense reports, and CV updates
- Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and applicable requirements
Requirements
What you’ll need- Oncology experience
- Qualified and clinically experienced physician
- Physician MD, ideally with medical thesis, trained in a clinical setting
- Minimum of 4 years of active clinical experience
- Specialization in internal medicine or general practice preferred
- Experience in the pharma industry or CRO in medical, project management, global pharmacovigilance, or another relevant medical function, ideally in Clinical Development
- Understanding of relevant regulations and guidance including ICH-GCP
- Experience with data visualization systems and IT systems
- Proficiency with Windows and MS Office (Word, PowerPoint, Excel, Outlook)
- Proficiency in written and spoken English and local language
- Excellent interpersonal, active listening and influencing skills
- Strong analytical, systematic, and well-structured working style
- Strong presentation and training skills
- Ability to work proactively and collaboratively in an international environment
- Ability to use digital technologies to access information, solve problems, communicate, navigate, learn, and apply knowledge in a digital environment
Benefits
Comp & perks- Equal opportunity employment
- Required training curriculum
- Compliance with Parexel processes, ICH-GCPs and other applicable requirements