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Pharmaceutical Product Development Ppd Work Values
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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:
Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.
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
Information about Pharmaceutical Product Development Ppd
Company Rank: Not Available
Average length of employment : 1 year
Average salary of employees: $80,000
These are some of the questions we asked our climbers about their experiences with Pharmaceutical Product Development Ppd:
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| Were your performance expectations clearly communicated? | 0.0 |
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| Did you feel like your personal contribution was important? | 0.0 |
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| Was your career path clearly outlined and discussed? | 0.0 |
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| I would recommend this as a place of employment. | 0.0 | |
| I believe in the purpose of this organization. | 0.0 | |
| I would work for this organization again. | 0.0 | |
| I feel employees are fairly compensated. | 0.0 |
