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:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

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: