Study Responsible Scientist

Kelly Services is currently seeking a Senior Clinical Project Scientist (Associate Director) for a long-term engagement with one of our Global Pharmaceutical clients.

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

RESPONSIBILITIES:

• 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 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

EDUCATION AND EXPERIENCE REQUIREMENTS:

• A minimum of a bachelors degree is required; and advanced degree (M.D., Ph.D. Pharm.D.) 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 oncology therapeutic area is required, preferably Non Small Cell Lung Cancer, Prostate and or Multiple Myeloma
• 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.
• Ability to travel up to 10% required.