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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Help develop individual clinical studies according to the clinical development plan within the assigned therapeutic area
- Provide scientific input for the safe and efficient execution of assigned studies, ensuring the highest quality and full compliance of all outputs
- Help develop high-quality program and study level documents and training materials aligned with project plans (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, investigator trainings, clinical study report and regulatory submission documents) in compliance with federal regulations, GCP and good medical practice
- Provide clinical science input into design and review of eCRF, SAP, and TLFs
- Support the scientific data analysis and interpretation and help write clinical study reports, internal and external scientific meeting presentations, and publications
- Support the medical monitoring and oversight of individual clinical studies with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, including ongoing review of blinded data, use of data visualization tools and programmed reports
- Identify clinical data trends, issue and resolve corresponding queries, ensure consistency of medical coding and other important data and identification of cases for medical review
- Ensure all questions / issues requiring medical oversight are brought to the attention of the Medical monitor
- Manage the processes and partnerships required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, clinical events committee)
- Collaborate with internal and external partners to ensure translation of the clinical protocol into operational deliverables, serve as primary contact for protocol guidance, provide training to the clinical execution team
Requirements
What you’ll need- Bachelor's degree, or equivalent with minimum of 5 years' experience in the biotechnology or pharmaceutical industry (or biomedical research organization) required; OR Advanced degree (Master's, PhD) with relevant clinical focus and minimum 3 years experience
- Knowledge in the drug development processes for pharmaceuticals with experience in biotherapeutics desirable (e.g. therapeutic proteins, monoclonal antibodies)
- Demonstrated ability to use systems and tools (e.g., EDC systems) for data collection, analysis and reporting
- Ability to work collaboratively in a matrix environment is necessary
- Experience working with CROs and AROs, including providing oversight
- Proficient knowledge and technical skills to support study specific data review, trend identification, data interpretation
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Development PlanECRF DesignStatistical Analysis Plan (SAP)Clinical Study Report WritingData InterpretationMedical CodingTrend IdentificationData VisualizationBiotherapeutics KnowledgeDrug Development Processes
Soft Skills
CollaborationProblem SolvingCommunication