Kelly is currently seeking a Associate Director/Principal Clinical Development Scientist for Immunology an on-going opportunity to work for one of the largest well known global pharmaceutical companies in the world.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
The Associate Director/Principal Clinical Development Scientist is dedicated to the development and execution of clinical trials.
The Principal Clinical Development Scientist provides active scientific contribution to a cross-functional clinical team. Specifically, develops the pediatric trial protocol and trial materials, takes responsibility for coordinating completion of study reports, and supports preparation of relevant documents for regulatory filings.
Responsible for the execution, safety monitoring, and reporting of pediatric clinical trials in collaboration with study responsible physician.
Participate in the development of clinical study documents (e.g., protocols, informed consent documents, case report forms).
Support activities related to the start-up and execution of new clinical trials; clinical lead supporting the Global Clinical Development Operations group with trial set up, conduct, and monitoring, and database locks.
Perform clinical data review and assist in the preparation of clinical safety presentations and reports.
Support monthly medical monitoring data review activities.
Assist with tracking of safety events, review of new SAEs, and composing adverse event narratives
Responsible for data review in conjunction with other clinical team members prior to database locks
Assist in the preparation of the clinical content of drug safety documents and reports such as the investigator brochures, DSURs, and other regulatory response documents.
May assist with managing other vendor activities such as laboratory, histology or imaging.
Other activities as determined by study team and phase of trial (start-up, study execution and close out).
A minimum of a Bachelor's degree is required; advanced degree (MS, PhD) and clinical experience/degree (MD, RN, NP, RD, or PharmD) are preferred.
Pediatric specific experience is required.
A minimum of at least 5 years of clinical research and development experience within the Pharmaceutical OR CRO industry is required.
Proficient knowledge of medical terminology is required.
Strong organizational skills, written and verbal communication skills are required.
Excellent time management skills with the proven ability to plan and track deliverables and timelines are required.
Ability to operate with limited day to day supervision is required
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