Real-Time Decision-Making: How Quintiles Accelerates Trial Conduct with Fast, Easy Access to Data

Today’s pharmaceutical and clinical research companies generate a previously unimaginable trove of real-world data to determine the validity of their clinical trial decisions. Quintiles, the global leader in contract research trials, is currently running clinical trials, phases 1 through 4, in over 60 countries – requiring access to need-to-know information anywhere, anytime.
With the market-leading Oracle Health Sciences InForm EDC platform, all stakeholders are now able to meet the challenges of how to maximize the value of data resources to determine how to help sponsors get their products to market as quickly as possible.

Highlights include:

• Quintile’s perspective on the changing market landscape
• The challenges of using real-world evidence in R&D and commercialization
• Demonstrating value through real-time decision-making

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Officer Pharmacovigilance Wipro BPS (A division of Wipro Limited)-Delhi-opportunity for fresher

Dear Candidate, 

Wipro BPS is hiring for Pharmacovigilance Business. 

Please find the JD below, if interested please walk-in to the below address with the required documents.

Address: A-23, Mathura Road, Sarita Vihar (Near Sarita Vihar Metro Station)

Walk-in date: 27th Oct 2015

Walk-in Time: 1pm - 4 pm

Contact Person: Bipasha Bose

Qualification: Education: Bachelors / Masters in Pharmacy Registered Pharmacist

Valid PAN CARD available

0 - 1 year experience

Skills:

Excellent English Communication both written and Spoken

Performing preliminary step of Pharmcovigiliance that case intake

Doing research work on adverse events or product complaints, or with an inquiry about the human health product

Receiving calls from consumers and health care professionals with reports

Verbal Probing for necessary information including but not limited to the adverse event(s), the patient's medical history, Suspect product, concomitant drugs involved if any, and medication history of patient

Answering to the inquiries, and respond to inquiries in a knowledgeable manner

Completing various safety reports regarding the contact through computer based database system

Receiving adverse drug reaction or adverse event information Medical coding of terms according to Med DRA. WHO medical dictionary Filling AEM (Adverse event management) forms and generating adverse event reports according to ICH-guidelines E2A, E2B, E2E Writing narratives for adverse events

Ability to work under pressure and deliver

Comfortable working in Voice Process

Comfortable with night shifts

Immediate Joining 

Documents Required

Updated and Printed Resume

2 Passport Sized Colored Photographs

Govt. Photo ID

Certificate of Registration

 

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Sr. Clinical Process Associate / Clinical Process Specialist-Quintiles 3 - 8 yrs Bengaluru/Bangalore

 
3,00,000 - 6,50,000 P.A 

Dear Candidate,

Opening in Quintiles for Records Management Professionals.


Exp: 3 years - 6 years


Criteria: Candidates having experience in Clinical Records Management, CRC, Clinical Research Co- ordinators,Clinical Data Mining, Clinical Data Documentation, Clinical Data Validation can apply for this role.


Designation: Sr. Clinical Process Associate / Clinical Process Specialist

Job - Description

Purpose

Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.


RESPONSIBILITIES

Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines Establish and maintain effective project/ site communications
Create and maintain relevant project documents// trackers Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information Review, evaluate and recommend modifications to designated processes Oversee and participate in document management (creation, review, maintenance, storage, as applicable)
Participate in (study) team meetings and implement action items
Collaborate with the project lead/team members in creation/review of study documents
Act as point of contact for assigned deliverables for specific customers or projects
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to relevant stakeholders and/or line manager.


If interested please forward your CV to thenmozhi.r@quintiles.com

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Clinical Research Coordinator-Excel Life Sciences Pvt. Ltd.

Job Description

 

We are hiring ClinicalResearch Coordinator for Delhi, Mumbai and Hyderabad.

Eligibility criteria ,

- Life science graduate
- Minimum 2 year of experience as a CRC

Job Description:

o Conduct site/trial feasibility to identify & select the right site and investigator for the study
o Ensure timely compilation of all essential documents & assist in regulatory package preparation, timely submission, follow up with site EC to resolve any queries, and obtain approvals
o Ensuring site setup according to protocol, review patient data base & pre-screening, identify physician network
o Coordinate for Clinical Trial Supplies receipt, accountability & storage
o Prepare site team for study initiation visit and coordinate with monitor for the visit
o Assist in the process of administering the informed consent to the potential Subjects and discussing in detail the patient information sheet
o Ensure that site documentation remains current, accurate and complete
o Coordinate for lab samples collection and logistics; review of lab reports and update PI
o Review & implement appropriate recruitment/referral activities for active enrolment at sites
o Ensure CRF Completion and query resolution on specified timelines
o Coordinate in conduct of Monitoring visits and Audits (Internal or External)
o Ensure that monitoring/audit related findings are resolved within the timelines
o Ensure patient follow up visit and vist compliance; manage patient related reimbursement; site related payment
o Drug receipt, accountability, storage, dispensing and related documentation
o Ensure adherence to protocol guideline, regulations, ethical guidelines
o Coordinate and ensure timely reporting to all stakeholders
o Maintain study log(s) & study manuals
o Assit monitor with the site closeout activities
o Manage final reconciliation of Clinical Trial Supplies and archival of study documents at sites

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