ORACLE Certified training on Oracle Clinical

APHETA invites the application for the Value Added Oracle Authorized Training on Oracle Clinical from ORACLE University. This is a once in a life time opportunity for the students to build a prosperous future by having great job opportunities in the CLINICAL DATA MANAGEMENT Industries.

 This training Program is for students of pharmacy, biotechnology, medicine, clinical Research professionals and Doctors. The program will cover the essential functional topics using Oracle Clinical Data Management tools and also expose the students to an enterprise scenario through case studies. The Program will be organized by Oracle University. The duration of the course is 40 hours which will be taking place for 5 days, 8 hours per day.

Details of this training are as follows 

Program Name         : Training on ORACLE Clinical

Recognition              : From ORACLE

Certification             : From ORACLE

Duration                   : 40 Hours (8 hours / day)

Mode                        : Full Time (Classroom)

Fees                          : 45000 INR (Including tax)
Venue                       : Apheta, New Delhi (India)

Eligibility for this Training

Bachelor or PG Students from :

• Pharmacy 
• Biotechnology 
• Medicine 
• Medical Professionals 
• Clinical Research 
• Microbiology 
• BAMS, BHMS, BDS, BPT, BMLT 
• Other Life Science Graduates.

Venue for this Training

Apheta Institute of Clinical Research, 389, South Ex. Tower, 201(2nd Floor), Masjid Moth, South Ex. Part - 2, New Delhi - 110049 (India)      

Schedule for this training

Day 1
System Overview, Basic Study Setup
Global Library Management

Day 2
Simple CRF modeling
CRF modeling for PDF

Day 3
Data Entry
Discrepancies, Data Clarification Form

Day 4
Validations and Derivations
Batch Data Loading, Laboratory Overview

Day 5
Data Extract and Access from SAS
Data Locking and Security, Copy Groups.
Simulated Oracle Training content for future practice

Topic Covered in this Training

CRF  Review

Browsing Oracle Clinical

Object in Oracle Clinical

Setup a Program, Project, Study

Planning details, Study Design, Study Statuses

Setup Planned Events

Add Sites, Investigators and Patient Positions

Manage Treatments, Schedules

Create, Maintain Global Library objects

Define & Copy DCM and DCI

Lab Ranges, establish unit of Measure, standard Lab Ranges

Lab Assignment criteria

SQL

PLSQL

Validation Derivation Procedure – Edit Checks

Entering CRF Data

Modify DCI

Discrepancy Management System

Data Clarification Form

Overview of Batch Data Loader

Data Extracts

QC Checking and Data Locking

Case Study (CDM Project assignment)

The Program will be organized by Oracle University and the following deliverable will be extended as a part of the training from Oracle University :

1. Software Environment during the training. 
2. Course Content
3. Training Methodology - Slides 
4. Completion Certificate duly signed and endorsed by Oracle University

Process of Application for this training

To book your seat, call to the following Number OR Visit the Institute

Apheta Institute of Clinical Research
389, South Ex. Tower, 201(2nd Floor)
Masjid Moth, South Ex. Part - 2
New Delhi - 110049
Ph: +91 11 45782279
Mob : +919555718847

 To apply online CLICK HERE 

Benefit of this Training

• Students will become trained by Oracle professionals .
• This will provide an added advantage to their academic qualification. 
• Students will be entertained by all the pharmaceutical, biotech, medical device and clinical data management companies who are working on Oracle. 
• Certificate will be provided by the Oracle University. 
• Diversity in the job prospects for the students. 
• Enormous use of Oracle clinical by the companies, create huge number of job openings in this field

Opening for Regulatory Affairs Manager : Intertek, Canada

Organization :Intertek

Job Title : Regulatory Affairs Manager

Location : Mississauga, ON Canada

Qualification : Minimum B.Sc. (advanced Science university degree, e.g., Pharmacology, Pharmacy or related discipline preferred)

Experience : 

• Minimum of 6 years regulatory experience in Regulatory Affairs.
• Thorough knowledge of new product and process development, current regulatory issues in Canada, United States, and Europe.
• Good technical writing skills and the ability to review and critique safety, efficacy, and quality.
• Excellent interpersonal skill and organizational, time management and communication skills are essential.
• Demonstrated leadership ability.

Job Responsibility : 

As Regulatory Affairs Manager, you will work with other in-house Regulatory Affairs professionals in the day-to-day issues associated with regulatory affairs, such as working actively on projects, writing domestic and international regulatory submissions and strategy documents as well as directing compliance audits and keeping abreast of ongoing changes in regulatory and compliance policies and procedures.

As a member of the Pharmaceutical & Healthcare Group, you will:

• Provide global regulatory affairs consultative support.
• Manage and participate in the writing and preparation of eCTD compliant submissions and regulatory filings related to Rx and OTC drugs (including biologics), medical devices, Natural Health Products, cosmetics, and veterinary drugs.
• Review documents for IND/CTA, NDA/NDS, IDE/510(K)/PMA, PLA, etc. and associated amendments/supplements. This includes the evaluation, and interpretation of proprietary and published safety, efficacy, and quality data. Recommend changes for labelling, manufacturing and marketing for regulatory compliance.
• Be responsible for the management and quality control of regulatory projects.
• Participate in regulatory agency meetings.
• Develop global product strategies for new products.
• Keep abreast of regulatory procedures and changes by attending regulatory conferences.
• Supervise regulatory affairs staff.
• Project manager responsible for regulatory affairs projects being delivered to clients on time, on spec and on budget. Prepare proposals and project budgets to present to clients.
• Assist with the preparation of business development plans for the regulatory affairs area and for the Pharmaceutical and Healthcare Group. 

To see the original notification CLICK HERE

Job for Fresher in Max Neeman Contract Research

There are vacancies for fresher or experience in Max Neeman, New Delhi on the position of Medical Monitor.

Organization : Max Neeman

Job Title : Medical Monitor

Location : New Delhi

Qualification : MBBS/BDS/BHMS/BAMS

Experience :  Fresher can apply

Job Responsibility :

• Design, develop, prepare and initiate clinical study protocols and required documentation in compliance with project plans, federal/DCGI regulations, GCP and good medical practice.
• Participate in the selection of clinical investigators; provide proper investigational profile for study. Visit selected sites to trouble-shoot, train/retrain staff, if needed.
• Assist the client in planning the overall strategy for clinical drug product development as and when required. 
• Provide medical supervision and training for project teams, study investigational sites, other involved organizations, for the understanding and delivery of study protocol.
• Provide medical and scientific input to review of clinical data, patient medical safety data and laboratory values; maintain an ongoing assessment of the safety profile, and efficacy data.
• Provide medical surveillance on Serious Adverse Event (SAE) reporting, follow-ups, including after hours coberage of medical emergencies.
• Participate in the planning, writing and review of Clinical Study Reports, regulatory updates and submissions.
• Continuing research of new scientific developments.
• Analyze and interpret study data and preapre reports.
• Serve as the primary medical contact with academic experts, collaborators and opinion leaders.
• Participate as an active member of multidisciplinary teams to successfully achieve corporate goals. Specific responsibilities include interacting with project management and clinical operations to provide estimate for operational budgets, and assess laboratory requirements. 

To see the original notification CLICK HERE

Clinical Research Associate Job in Mumbai

There are vacancies for Clinical Research Associate in Cavance.

Organization : Cavance
Job Title : Clinical Research Associate
Location : Mumbai
Qualification : University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Experience :  Minimum 18-months of clinical research experience including demonstrated competency in site monitoring (including pre-study, initiation, routine monitoring and closeout visits). 

Job Responsibility :

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned.
• General On-Site Monitoring Responsibilities:

1. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. 
3. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
4. Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.
5. Prepare accurate and timely trip reports.

• Responsible for aspects of site management as prescribed in the project plans.
• Responsible for aspects of registry management as prescribed in the project plans.
• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management.
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management.
• Provide coverage for clinical contact telephone lines, as required.
• Update, track and maintain study-specific trial management tools/systems.
• Generate and track drug shipments and supplies, as needed.
• Track and follow-up on serious adverse events as assigned.
• Implement study-specific communication plan as assigned.
• Attend investigators’ meetings, project team meetings and teleconferences, as needed.
• Assist Senior CRA in managing investigator site budgets.
• Perform other duties as assigned by management.

To Apply this position Click Here