Clinical Project Manager

Clinical Project Scientist (Study Responsible Scientist)6-12 month contract with extension$100-115 an hourServices Overview: 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 internalexternal meetings, including investigator meetings and governance committees· Trains and mentors localcentral study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities· Participates inleads 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 protocolQualifications: · 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.

Created: 2024-11-09