Note: The job is a remote job and is open to candidates in USA. Fortvita Biologics is a company focused on clinical development, and they are seeking a Clinical Scientist to join their team. The Clinical Scientist will be responsible for the design, monitoring, and data analysis of clinical trials while collaborating with cross-functional teams and ensuring the integrity of study data.
Responsibilities
- Design, provide oversight, and support site and subject retention
- Ensure successful completion of documents (including clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
- Participate on study teams and cross-functional teams as appropriate, and as delegated by the Vice President, Clinical Development
- Ensure consistent use of language and criteria across multiple endocrine projects
- Ensure study integrity, and track accumulating safety and efficacy data
- Anticipate obstacles within a clinical trial, and implement solutions
- Analyze, evaluate, and support accurate interpretation and reporting of clinical data
- Contribute to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions
- Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
- Collaborate with and serve as a clinical research resource for cross-functional colleagues to optimize product development
- Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
- Support corporate strategic and organizational initiatives
- Assist with commercial activities as needed Complete assigned tasks thoroughly, accurately, and on time
- Adhere to rigorous ethical standards
- Other duties as assigned
Skills
- Advanced degree e.g. Ph.D., Pharm.D., MS, or equivalent
- Strong track record of scientific and clinical inquiry
- Understand statistical concepts and clinical trial design
- Understand the connection between nonclinical data and clinical data
- At least 2 years of experience with clinical trial design and execution
- At least 2 years of pharmaceutical industry experience
- Experience with regulatory submissions and interactions
- Possess excellent communication skills (both written and verbal)
- Learn quickly, follow complex directions under pressure
- Multi-task while remaining organized and attentive to detail
- Work hard, be a trustworthy and collaborative team player
- Take initiative and solve problems of moderate complexity
- Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
- Lead both directly and by example
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