PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients
Post: Project Assistant
Job Description:
The basic purpose of the Project Assistant is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.
- Reviews regulatory documents for proper content
- Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools
- Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departments
- Assists with the identification of potential investigators and development/distribution of initial protocol packets
- Creates meeting agendas and minutes
- Coordinates team conference calls and distribution of meeting minutes
Candidate Profile:
Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
- Excellent communication and interpersonal skills
- Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
- Flexibility to reprioritize workload to meet changing project timelines
- Responsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
- Excellent English and grammar skills
- Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)
- Ability to mentor and train new Project Assistants as needed
Additional Information:
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 106937
End Date: 20th June, 2012
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