Senior Clinical Data Manager Jobs in Delaware

Overview

This position is responsible for working with the physicians within Clinical Development to provide clinical research support for programs as assigned by phase or therapeutic area.

ESSENTIAL FUNCTIONS OF THE JOB (KEY RESPONSIBILITIES)

• Maintain updated knowledge of competitive landscape in regard to assets with similar MOA and/or evolving standards of care for indications of interest.
• Serve as liaison to project teams, CRO's, Clinical sub-teams, and others.
• Clinical lead for study abstracts, posters, oral presentations, and manuscripts for assigned studies, ensuring inclusive and diverse representation in all materials.
• Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
• Represent clinical development on project teams.
• Monitor, review and summarize safety and efficacy data in ongoing studies.
• Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
• Development of protocols for clinical studies.

QUALIFICATIONS (MINIMAL ACCEPTABLE LEVEL OF EDUCATION, WORK EXPERIENCE, AND COMPETENCY)

• Willingness to travel up to 20% or as business needs require, with accommodations available for individuals with disabilities.
• Strong analytical skills.
• Strong written and verbal communication skills.
• Ability to work independently, manage multiple priorities, and thrive in a dynamic environment.
• Experience in oncology drug development is preferred, but not required, to encourage candidates from diverse backgrounds to apply.
• Minimum of several years of experience in research with relevant drug development experience are required. Alternative drug development experience will be considered.
• Degree in scientific/life-sciences field or equivalent experience. Advanced degrees such as Pharm.D. or Ph.D. are valued but not required.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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