Senior Clinical Scientist

Vor 6 Tagen

Deutschland Autolus Ltd Vollzeit

Role Summary

The current position will be in clinical development in the area of Hematology /Oncology with Advanced Therapy Investigational Medicinal Products (ATIMPs).

The Clinical Scientist (Manager) using clinical, scientific and technical disciplines supports high quality protocol development, study execution and data interpretation. They will be responsible for supporting the Lead Clinical Scientist with clinical deliverables on one or more interventional clinical trials.

Clinical scientist responsibilities impact key elements of the study lifecycle including protocol development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development.

Key Responsibilities
- Provides support in the writing of protocol outlines, protocols, and amendments in collaboration with the Clinician, Translational Medicine, Clinical Operations, and other relevant groups.
- Ensures appropriate CRF design and implementation.
- Partners with data management to develop data review plan for review of data.
- With support from the Lead Clinical Scientist, the Clinical Scientist (Manager) will review all patient level and cumulative data per the data review plan.
- Review in detail electronic Case Report Forms (eCRFs) for all patient data as well as non-CRF data types (eg translational data).
- Reviews safety data, SAE reports and ensures clinical documents are updated as required.
- Provide input to data packages for program or company level safety meetings.
- Provide input to protocol deviation reporting and reviews.
- Collaborates with Lead Clinical Scientist to provide medical/scientific guidance during the execution of the study.
- May perform and coordinate clinical sciences deliverables across studies at the program level.
- Ensures TMF compliance for clinical sciences study level TMF documents.
- Answers specific site protocol questions as needed.
- Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, and for Autolus site facing roles and vendor / CRO staff.
- Identifies scientific quality issues to discuss with study team members so that corrective actions may be instituted.
- Escalates protocol-related issues requiring complex medical expertise to the Clinician.
- Escalates operational issues to the appropriate operations study team member.
- Provides scientific input to and review of CSRs including writing of narratives.
- May support and contribute to various sections of regulatory documents (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses).
- Identifies, significantly contributes to, or leads continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
- Support, organize Investigator meeting, scientific advisory boards, regulatory meeting and other program or company specific activities as needed.
- Participate in organizational initiatives.

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