#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.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.
