Clinical Project Scientist (Oncology)

<strong>Clinical Project Scientist (Oncology)</strong><br><br>The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.<br><br>Responsibilities:<br><ul><li>The following responsibilities will be demonstrated in varying degrees of participation and leadership: </li><li>Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study</li><li>Develops clinical research protocols, study case report forms, informed consent; </li><li>Develops the medical review plan to support the statistical analysis plan</li><li>Plays a key role in the medical review of the study data and assists in coding, analysis and documentation</li><li>Validates and interprets results of phase I - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals</li><li>Ensures team member adherence to clinical research guidelines and safety procedures</li><li>Communicates detailed outcomes and results of research findings to relevant partners</li><li>Provides input in managing project budgets and projections</li><li>Serves as liaison to global clinical sites for medical questions related to the clinical research trial ;</li><li>Presents study status at internal/external meetings, including investigator meetings and goverance committees </li><li>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</li><li>Participates in/leads interactions with health authorities</li><li>Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies</li><li>Reviews and maintains correct standard operations, procedures and protocol </li></ul><br>Education & Experience:<br><ul><li>A minimum of a bachelor's degree is required; and advanced degree is preferred.</li><li>A minimum of 4 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc) is required.</li><li>Experience in oncology therapeutic area is preferred.</li><li>Significant experience with clinical trials including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.</li><li>Excellent written communication, oral communication, and presentation skills are required.</li><li>The individual must have demonstrated ability to work in a team environment.</li></ul>