Available Positions
Demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines; good communication skills; knowledge and ability to effectively manage a clinical trial with minimal supervision.
Description
The Clinical Study Manager (CSM) organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development P
Has demonstrated knowledge of, and competence in, application of CRFs, GCPs and ICH guidelines. Has demonstrated the use of good communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
Description
Responsible for planning, conducting and tracking clinical research studies in compliance wit
This position in Regulatory Affairs:
-involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's preclinical and clinical drug development programs.
-provides guidance to multidiscplinary teams on the content, format, style of Regulatory submissions to Regulatory authorities.
-edits scientific sections of submi
Duties/Responsiblities: Responsible for review & management of serious adverse events during clinical trials, participation in management of SAE; interact with FDA and participate in advisory boards, development and review of scientific writing projects, including study protocols, study reports, manuscripts, monographs, FDA briefing documents & regulatory analysis; create & conduct employee train
Oversee and manage all activities related to the conduct of clinical research projects in order to meet deliverables and program objectives. Interacts with various internal and external vendors as well as clinical study sites. Periodically travels to assure compliance with protocol and clinical research project objectives. Clinical research is typically cyclical and some periods during the trial c
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's preclinical and clinical drug development programs. Manage process and people (several Regulatory Affairs Associates).
* Priovide guidance to multidiscplinary teams on the content, format, style of regulatory submission
Oversee and manage all activities related to the conduct of clinical research projects in order to meet deliverables and program objectives. Interacts with various internal and external vendors as well as clinical study sites. Periodically travels to assure compliance with protocol and clinical research project objectives. Clinical research is typically cyclical and some periods during the trial c
Our client is looking for a Validation Manager. In this role you will manage and review validation processes and procedures to current regulatory, industry and corporate standards.
The Validation Manager is responsible for the development, execution, direction and maintenance of validation programs for instruments, equipment, computer systems and other utilities and processes. Also responsible fo
This position is expected to perform a leadership role in statistical programming and reporting areas, including but is not limited to the following: statistical programming, validation and quality control of the statistical analysis datasets and output tables/listings/graphs; statistical programming and validation of database logical checks and study specific monitoring reports.
1. Design
CRT programming validation
Database extraction plan
Database extraction programming
Develop statistical analysis plan
Documentation of computer files
Electronic submission
findings)
ISS/ISE Analysis Plan
Perform data extraction for statistical analysis
Produce ISS/ISE analyses (e.g.
Produce ISS/ISE tables/listings/graphs
Produce statistical analysis (e.g.
Produce tables/listings/graphs
Program sta
|
How would you rate Pharmaceutical Clinical Associates, LLC?
Be the first to rate this company!
|
