Clinical Submission Specialist

Bachelors Degree in Life or Health Science, or Nursing Degree
Meets at least one of the following criteria:
-2 years experience in Study Start-up, or
-2 years of an equivalent experience with regulatory documents and knowledge of applicable FDA ICH/GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site setting (i.e. Study Coordinator, IRB Coordinator). Formal training in Medical Terminology
Or an equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job.

-Demonstrated understanding of applicable ICH Guidelines, FDA Good Clinical Practices, PPD and client Standard Operating Procedures/Working Practice Documents/PWIs
-Good computer skills, previous working knowledge of Clinical Trial
-Management System (CTMS)
-Excellent professional writing and verbal communication skills
-Must be self-motivated and have a positive attitude
-Excellent organizational and coordination skills with strong attention to detail.

The basic purpose of this position may include, but is not limited to, activities related to obtaining Investigational Product (IP) approval for an individual or group of sites across one or more clinical study including:
-Site management
-Informed consent form review and approval
-Regulatory document collection, review and transmittal approval
-Adherence to project timelines & expectations

Objectives include the successful coordination of all regulatory and Ethics Committee (EC) tasks required for site IP approval in accordance with FDA Good Clinical Practices, ICH Guidelines and Global Standard Operating Procedures. Represents PPD in the global medical research community and develops collaborative relationships with investigative sites and client company personnel during the start-up of clinical trials.

With offices in 44 countries and more than 11,000 professionals worldwide, we are a leading global contract research organization, and we can offer you excellent career opportunities. Our company is growing, and our vision is to be the global leader in the industry based on consistent quality and execution, exceptional customer-aligned service and constant innovation.

As an equal opportunity employer, PPD believes that employees are the key to its success, and is committed to your professional growth. You will be joining a truly global enterprise that offers unrivalled variety, exceptional career scope and a caring, supportive culture that nurtures the ability of every individual.
To apply, please visit our web site at www.ppdi.com/careers.
For more information you can find us on www.ppdi.com.

PPD is an equal opportunities employer.