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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Oncology Clinical Development, including patient-level data review, clinical study documentation, and compliance with ICH-GCP regulations. Proficient in collaborating with cross-functional teams and contributing to data-driven decision-making in clinical trials.
Highest-signal resume keywords
Oncology Clinical DevelopmentClinical Data ReviewICH-GCP ComplianceClinical Study DocumentationCollaboration with CROs
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Patient-Level ReviewData CleaningStudy AnalysisSafety and Efficacy Data ReviewProtocol AmendmentsInvestigator's BrochureDSURICFRECIST AssessmentsCombination Therapies
Soft Skills
Data-Driven Decision-MakingProactive Issue Identification
Tools & Technologies
VeevaClinical DatabasesCentralized Imaging Review
Certifications & Qualifications
PharmDPhD
Industry Keywords
Clinical DevelopmentPharmaceutical IndustryBiotechnology IndustryOncologySolid Tumors
About the role
Key responsibilities & impact- Support the Clinical Lead and Study Team in the scientific and clinical oversight of an oncology clinical trial
- Perform patient-level review of safety and efficacy data and contribute to data cleaning activities
- Support database lock preparation, study analyses, and Clinical Study Report development
- Coordinate Data Monitoring Committee activities and centralized imaging review vendors
- Contribute to protocol amendments, Investigator's Brochure, DSURs, ICFs, and Clinical Study Reports
- Interpret study results and support data-driven decision-making
- Collaborate with Clinical Operations, Data Management, Statistics, Safety, CROs, and investigational sites
- Identify and proactively address study, data, or operational issues
- Ensure activities comply with ICH-GCP and applicable regulations
Requirements
What you’ll need- PharmD, PhD, or equivalent degree in Life Sciences, Biomedical Sciences, or a related field
- Strong experience in Clinical Development within the pharmaceutical or biotechnology industry
- Experience in Oncology Clinical Development, preferably in solid tumors
- Experience with combination therapies involving immunotherapy, targeted therapies, and/or chemotherapy
- Experience in clinical data review, patient-level review, and data cleaning
- Good understanding of oncology efficacy and safety endpoints, including RECIST assessments
- Experience contributing to clinical study documents, including IB, DSUR, protocol amendments, and CSR
- Experience working with CROs, vendors, and cross-functional study teams
- Fluent English, written and spoken
- Experience with DMC activities or centralized imaging review is a plus
- Experience with Veeva and clinical databases/listings is desirable
Benefits
Comp & perks- Opportunity to join a young and ambitious healthcare company with 900 employees
- Diverse and stimulating projects through a one-stop provider service model combining full-service, functional service provider, and consulting
- Opportunities to collaborate with leading experts and contribute to scientific, operational, and human knowledge
- Inclusive environment fostering collaboration and individual growth
- Environment that values natural talents, encourages boldness, pushes boundaries, and cultivates potential