Clinical Scientist
On-sitePittsburgh, Pennsylvania, United States
Job Summary
Provide scientific expertise to inform clinical study design and analysis plans. Drive protocol development, content, and quality review while ensuring study plans and documentation are accurate and complete. Partner with data management to develop case report forms, review patient-level and cumulative data, and adjudicate protocol deviations. Participate in protocol training for site initiation visits and investigator meetings, including vendor and CRO staff. Identify scientific quality issues to discuss with investigators and sites, assist in preparing clinical content for regulatory submissions, and support health authority information requests. Interpret and present study results by authoring Clinical Study Reports and supporting clinical publications. Ensure adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures. Requires advanced scientific degree, 3+ years drug development experience, and ability to travel domestically up to once a month and internationally as needed.
Required Qualifications
- Advanced scientific degree
- 3+ years of drug development experience
- equivalent clinical research experience at CRO or academic institution
- Must be able to travel domestically up to once a month and internationally as needed
- Proficient at clinical data review including query generation and management
- Strong understanding of Good Clinical Practices
- Experience in monitoring and/or coordinating clinical trials required
- Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
- Ability to interact with all levels of staff to coordinate/execute study activities
- Ability to handle several priorities within multiple, complex trials
Desired Qualifications
- preferably a PhD in science or health-related field
- Prior project team leadership experience preferred
- Ability to work onsite in Pittsburgh is highly preferred
- Non-local candidates with direct industry experience and doctorate-level degree may be considered
- Ophthalmology experience a plus, but not required
- Ability to work independently
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