Clinical Research Coordinator providing assistance on clinical research studies including recruiting and organizing data. Supporting patient consent and clinical tests within a hybrid work setting.
About the role
- Senior Manager, Clinical Scientist in Hematology leading clinical study development and execution. Collaborating with cross-functional teams to ensure integrity of clinical data.
Responsibilities
- Lead in the development, evaluation, planning and execution of clinical studies
- Ensure integrity and interpretation of study data
- Contribute to program team meetings, scientific advisory boards, study steering committees
- Develop/maintain understanding of therapeutic disease area(s) and drug candidate
- Apply basic scientific expertise to support clinical research and development studies
- Author clinically relevant sections and review other scientific portions of clinical trial protocols
- Maintain compliance in accordance with FDA, EMEA, ICH and GCP guidelines
Requirements
- Bachelor’s Degree required; Advanced degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
- ≥ 8 years of pharmaceutical clinical drug development experience
- Proven knowledge of drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing skills
- Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
- Proven track in clinical trial process improvements.
- Considerable organizational awareness, including significant experience working cross-functionally.
Benefits
- health and wellness programs
- fitness centers
- equity awards
- annual bonuses
- paid time off
Job title
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