#x 9; 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, sci... more details
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.
PRINCIPAL 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 CAR T 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.
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