The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.
Key Responsibilities and Deliverables: • Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study • Develops clinical research protocols, study case report forms, informed consent • Develops the medical review plan to support the statistical analysis plan • Plays a key role in the medical review of the study data and assists in coding, analysis and documentation • Validates and interprets results of phase 3, 3b, and 4 investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals • Ensures team member adherence to clinical research guidelines and safety procedures • Communicates detailed outcomes and results of research findings to relevant partners • Provides input in managing project budgets and projections • Serves as liaison to global clinical sites for medical questions related to the clinical research trial • Presents study status at internal/external meetings, including investigator meetings and governance committees • Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities • Participates in/leads interactions with health authorities • Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies • Reviews and maintains correct standard operations, procedures, and protocol
Qualifications: • A minimum of a bachelor's degree is required; and advanced degree is preferred. • A minimum of 3 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required. • Experience in immunology therapeutic area is preferred. • Significant experience with clinical trials including development of protocols, case report forms, informed consent and study initiation and monitoring preferred. • Excellent written communication, oral communication, and presentation skills are required.