Clinical Scientist (Remote)

Description This job is only open to US and UK at this time. Job Summary The Clinical Scientist will work collaboratively with the clinical lead and team to execute the clinical program(s). Their primary deliverable is to assist in planning, executing, and reporting of global clinical trials. The clinical scientist also contributes beyond database release to support effective study reporting and close-out; submission activities; and audits/inspections, as appropriate. Job Responsibilities Maintain a thorough understanding of assigned protocols and protocol requirements. Contribute to communication of clinical study patient results internally and externally. Conduct activities related to data generation and validation, especially clinical data review. Generate additional data analysis based on TFLs in close collaboration with biostatistics. Analyze clinical study data. This may involve ensuring consistent quality data reviews, identifying clinical trends, reviewing, and summarizing scientific data. Author/review clinical study documents and clinical portions of regulatory documents. Participate in cross-functional teams and drive scientific evaluation and trial development activities. Contribute to authorship and review process for scientific publications and presentations. Ability to transform scientific data to graphical presentations, and competent in Microsoft Office programs. Sound scientific and clinical understanding and experience in medical writing of study results and regulatory documents. Very good command of biostatistics and ability to generate aggregated data overviews based on TFL data. Possible Additional Responsibilities Responsible for key elements of the planning, executing, and reporting global clinical trials. Responsible for clinical components of inspection readiness for all aspects of the study conduct. May be responsible for program planning and compliance with 'Inspection Readiness'. Assist in ensuring regulatory compliance for clinical trials and reporting. Writes standard protocols and amendments. Partner with study management to ensure that protocol and Monitoring Plan are consistently and appropriately implemented across investigator sites and countries. Ensures appropriate CRF design and high-quality data review plan in place. Responsible for ongoing data review and signal detection during study execution. Proactively identify and resolve clinical-related issues as they arise. Qualifications Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD., or equivalent qualifications. Minimum of 7 years total relevant experience (including biotech/pharmaceutical industry and academia), with at least 4 years in a biotech/pharmaceutical industry. Ability to transform scientific data to graphical presentations, and competent in Microsoft Office programs. Sound scientific and clinical understanding and experience in medical writing of study results and regulatory documents. Very good command of biostatistics and ability to generate aggregated data overviews based on TFL data. Knowledge and/or experience in rare diseases is a plus. Demonstrated ability to support conduct of clinical trials in industry, academic, or research clinic setting. Demonstrated effectiveness in working in a multidisciplinary, matrix team situation. Direct therapeutic area expertise may be required in some instances. Understanding of scientific/clinical principles and ability to work across different therapeutic areas. Ability to instill customer confidence in ability to deliver to project deliverables. Extensive knowledge of clinical development process including in-depth knowledge and understanding of the principles of GCP. Ability to communicate effectively and appropriately with staff and investigator sites. Knowledge of the clinical development process, understanding concepts of Phase II-IV and principles of study design. Experience in all phases of the clinical trial including study start, conduct, and reporting. Ability to organize tasks, time, and priorities of self and others; ability to multi-task. Risk management and contingency planning expertise required. Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization. Ability to proactively communicate project issues and actions to mitigate risk and to ensure project members are aware of study status at all times. Knowledge and/or experience in rare diseases is a plus.

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