Clinical Scientist Principal
4 weeks ago
Job Title: Clinical Scientist Principal
Job Summary:
We are seeking a highly skilled Clinical Scientist Principal to join our team at Davita Inc. The successful candidate will provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities.
Key Responsibilities:
- Work with cross-functional teams to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
- Conduct medical monitoring reports, safety reviews, site interactions, and reviewing TFLs.
- Provide analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead.
- Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety.
- Provide clinical operational support for Data Monitoring Committees, including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
- Develop protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents with minimal direction from the Medical Lead.
- Collaborate with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; respond to or triage questions for appropriate escalations.
- Represent Davita Inc. to outside personnel in the development of clinical protocols and study conduct.
- Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
- Lead literature reviews as needed.
- Prepare scientific material for conference presentations or publications.
Requirements:
- Bachelor's degree in the Life sciences.
- Typically requires 6 years of experience in clinical or pre-clinical research in the pharmaceutical industry or healthcare setting, or the equivalent combination of education and experience.
What We Offer:
Davita Inc. offers a competitive salary and benefits package, including a generous paid time off policy, 401(k) matching, and opportunities for professional growth and development.
Flexibility:
This role is eligible for our Flex @ Davita Program, which offers flexible work arrangements to support work-life balance.
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