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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical trial design and execution, particularly in Phase I-IV trials, with a strong focus on oncology. Proficient in medical monitoring, data management, and regulatory compliance, while effectively leading teams and collaborating with stakeholders.
Highest-signal resume keywords
Clinical Trial DesignMedical MonitoringOncology Therapeutic-Area ExperienceData Management ActivitiesOral And Written Communication Skills
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ExecutionData Issue ResolutionProtocol DevelopmentMedical Monitoring Plan DevelopmentSPECTRUM ReconciliationEDC ProficiencyCRF ManagementBiospecimen SpecificationsEndpoint ManagementAdverse Event Review
Soft Skills
Team MotivationDelegationFlexibilityListening Skills
Tools & Technologies
Microsoft OfficeOneNote
Industry Keywords
PharmaceuticalClinical Drug DevelopmentBiotechCROICH-GCP
About the role
Key responsibilities & impact- Lead or support studies depending on size and complexity
- Accountable for clinical and scientific execution of the protocol when serving as study lead
- Act as the clinical point of contact for scientific issues and questions for internal and external stakeholders
- Lead trial design and endpoint development in collaboration with Clinical Development
- Serve as scientific lead on the Clinical Trial Team
- Lead Medical Monitoring activities, including developing the Medical Monitoring Plan and reviewing SAE reports
- Monitor clinical data issues, central laboratory reports, external data, safety data, and critical values
- Prepare scientific slides and present protocol information at Investigator Meetings
- Participate in database lock activities
- Reconcile and review protocol deviation classifications in SPECTRUM
- Set up and support SAC, DMC, and adjudication committees
- Collaborate on protocols, amendments, governance reviews, informed consent, study documents, and protocol clarification letters
- Provide scientific input for data management activities, EDC, DRP, CRFs, randomization, laboratory, biospecimen, and imaging specifications
- Co-author newsletters and collaboratively plan CSRs, CTDs, and WMAs with medical writing
- Support publications, presentations, trial-results communications, operational reviews, and clinical specifications for external vendors
- Mentor other Clinical Scientists as needed
- 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- Experience reviewing and resolving study-related data issues, including queries, medical records, and data errors requiring site clarification
- Demonstrated oral and written communication skills
- Proficiency in Microsoft Office (Outlook, Word, Excel, and PowerPoint) required
- OneNote experience preferred
- Ability to motivate a team, handle and delegate responsibilities, listen to feedback, and remain flexible
- Minimum 7 years of pharmaceutical and/or clinical drug development experience with a BS/BA, or minimum 5 years with an MS/PhD, in the last 10 years
- Minimum 2 years as a lead Clinical Scientist in Phase I-IV clinical trials with pharmaceutical, biotech, or CRO company experience in the last 5 years
- Minimum 2 years of medical monitoring experience, including reviewing patient data and resolving discrepancies involving adverse events, adverse-event trends, endpoint management, and labs
- Oncology therapeutic-area experience required
- Indication-specific experience preferred
- Degree in Life Sciences
- Bachelor of Science, Bachelor of Arts, Master of Science, or PhD
Benefits
Comp & perks- Full-time employment
- Remote work arrangement