American Institute Of Pharmaceutical Technology

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	Oct 29, 2006 The AIPT Opened a Health Science Division to offer Healthcare / Nursing related courses at newest state of the art facility in Central New Jersey, USA ..

	March 16, 2007 The AIPT is going to Offer Executive MBA program in Kolkata, India from August 2007.

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Courses

US Campus

PG Diploma Courses

PHARMACEUTICAL CLINICAL DATA MANAGEMENT / ANALYST
COURSE : IC-107	Duration :	12 months
	Qualification :	Minimum BS or IT

Module - 1(Basic):

This course is designed for Quality Data Management and IT personnel responsible for Clinical Data Systems implementation, operation and compliance. The courses provide:

	Oversee the day-to-day activities and task management of the project team to ensure that a focus on quality
	Upon completion, valuable hands-on experience is gained with different coating systems in our pilot manufacturing plant.
	Budget and timelines on each project is reached and maintained. Ensure all necessary project specific training is provided to staff
	Deliver Project to Quality.
	Timeline and Budget Requirements.
	Manage Resources and Costs. Proactively identify resource needs and coordinate resources efficiently to meet project/department timelines. Maintain and Develop Processes and Systems.

Under general supervision, the CDM reviews data; assists in database design and testing; designs CRFs; designs and tests logic checks; generate queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; interfaces with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues; provides clinical data management expertise to all aspects of the study. The Health Access Network Data Manager (HAND) manages the maintenance and operation of the project database and works to continually monitor and improve the quality of data collection. Additionally, provides data entry support, creates reports, and implements quality assurance checks and corrections.

Module – 2 (Intermediate):

The intermediate module focuses on training include assisting in developing software package applications for data entry, report generation and qualitative and quantitative analysis queries; training end-users on database applications and software; and collating and analyzing data collected using basic descriptive statistics, cross tabulations and other advance statistical methods.

Also managing the retrieval and appropriate presentation of data for study collaborators and fonder, assisting in designing conceptual models for studies that require data mining and data analysis, and participating in the design and development of surveys, questionnaires, and other data collection tools.

Module – 3 (Advanced):

The advanced module provides an opportunity to engage in independent Clinical Data management projects. How to work closely with study sponsors on data management issues/activities and coordinates the receipt and processing of information for projects (e.g., coding dictionaries, format libraries, and transfer database specifications) as well as electronic data received from specialty groups utilized on projects. Submit project status reporting to HCRI project team and sponsors; coordinating the building, testing, validation, and maintenance of clinical databases; auto/manual coding of AEs, secondary diagnoses, and concomitant medications, as appropriate; Data cleaning and correction to ensuring databases are well-validated and ready for transfer and/or statistical analyses; and maintaining DM Standard Operating Procedures (SOPs) for assigned projects. S/he may also coordinate activities of Associate Data Managers as appropriate. Data management function in new device/drug development. Familiarity with PC in the Windows environment with knowledge of ORACLE, SQL, Domain ClinTrial / Clintrace, and/or SAS.

Knowledge of ICH / FDA guidance for Good Clinical Practice (GCP).

Module – 4 (Internship):

Students who are at the final stages of their program and have excelled in all aspects of their training may apply their expertise for an internship. These opportunities allow selected students to gain additional experience will handle assignments for different studies and follow up with issues related to errors found in the QC of patient numbers. Detail oriented, possess good organizational skills, knowledge of biological sciences, and/or medical terminology, good verbal and written skills, and be able to work flexibly across projects.

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