Pharmaceutical Product Development Ppd Work Values

Daily Duties at Pharmaceutical Product Development Ppd:

Monitored three Phase II/III rescue pediatric diabetes clinical trials with tight time lines for Bristol Myers Squibb. Responsible for reviewing and approving over 38 local IRB informed consents submitted to PPD for a pediatric clinical trial while performing site maintenance for assigned 15 sites., Coordinated regulatory training of the team from quality assurance. Responsible for creating drug inventory spreadsheet for all sites before the pharmaceutical company shutdown during the holidays ensuring all sites in the pediatric trial had adequate drug, Completed all closeout visits for assigned sites and additional closeouts for team members. Presented at a teleconference including all investigators and the sponsor, Worked as a regional clinical research associate on a Double Blind Randomized Phase IIB Type 2 Diabetes clinical trial for adults, Reviewed and approved regulatory document submission to sponsor, study startup and study initiation visits while training new clinical research associates,

What they like about Pharmaceutical Product Development Ppd:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

pharmacovigilance, Sr. clinical research associate, Immunology, Oncology, Virology, Endocrinology, Cardiac markers, Data reconciliation, Clinical trials, Global delivery, Protocol development, Medical case management, Risk management, Clinical narratives, SAE reporting, Medical devices, IND queries, Regulatory reporting, Global unblinding, Safety database, Adverse event reporting, 21 CFR ICH, MedRa coding, WHO dictionary, IND reports, Regulatory submissions, Clinical study reports, Perodic Safety Update Reports PSUR, Quality auditing, Site Management, Monitoring, Teaching adults, Investigator meetings, Regulatory compliance, Internet recruiting, Drug development, Query resolution, Triage case workload, Oracle Argus II

Skills

These are some of the questions we asked our climbers about their experiences with Pharmaceutical Product Development Ppd: