Clinical Project Scientist (Oncology)

The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.

Responsibilities:

• The following responsibilities will be demonstrated in varying degrees of participation and leadership:
• 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 I - IV 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 goverance 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

Education & Experience:

• A minimum of a bachelor’s degree is required; and advanced degree is preferred.
• A minimum of 4 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc) is required.
• Experience in oncology 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.
• The individual must have demonstrated ability to work in a team environment.